A Phase 2 interventional study of Ascorbic Acid and Pazopanib Hydrochloride in Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v8, sponsored by Academic and Community Cancer Research United. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment
Among 1,142 studies in Carcinoma, Renal Cell with a site in United States — 156 open to participants now, 280 under way, 26 of them phase 3. Carcinoma, Renal Cell · United States.
Among the 1,142 studies in Carcinoma, Renal Cell with a site in United States, this one is the 919th largest by enrollment of the 1,008 interventional ones that give a count, is one of 50 that started in 2018, is one of 382 in phase 2, and was the 710th registered.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
Browse Carcinoma, Renal Cell studies →156 of the 1,142 studies in Carcinoma, Renal Cell with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
University of Oklahoma · Sites in United States
Ages 18–100 · Men only
Roswell Park Cancer Institute · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18–100
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 308 Carcinoma, Renal Cell studies recruiting now, 255 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,142 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 488 · Phase 2 529 · Phase 3 74 · Phase 4 10
First in 1990; this study’s year is marked. 50 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5 is below the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Median enrollment 40 across the 1,008 interventional studies, 100 across the 87 observational. Of the 791 that completed or were terminated, 336 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
467 of 1,142 have an industry lead sponsor. The 10 most frequent:
Academic and Community Cancer Research United is the lead sponsor of 50 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
Academic and Community Cancer Research United has 1 study filed under Carcinoma, Renal Cell — fewer than ten, so there is no comparison to draw.
98 of the studies in Carcinoma, Renal Cell with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05678673Phase 3ExelixisStudy of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma | 2026-12-15 |
| NCT03592472Phase 3Xynomic Pharmaceuticals, Inc.A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) | 2026-12-30 |
| NCT03873402Phase 3Bristol-Myers SquibbA Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer | 2027-03-11 |
| NCT05863351Phase 3ECOG-ACRIN Cancer Research GroupFocused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study | 2027-08-31 |
Add all 98 to your calendar (.ics) → With an account.
Among the 1,142 studies in Carcinoma, Renal Cell with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized phase II trial studies how well pazopanib hydrochloride with or without ascorbic acid work in treating patients with kidney cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ascorbic acid may help pazopanib hydrochloride stop tumor growth and improve treatment survival. Giving pazopanib hydrochloride and ascorbic acid may work better in treating patients with kidney cancer.
PRIMARY OBJECTIVES:
I. To estimate and compare treatment failure-free rate at 40 weeks from randomization of patients with unresectable/metastatic clear cell renal cell carcinoma (ccRCC) receiving one of the following regimens: Arm A: pazopanib hydrochloride (pazopanib) 800 mg daily plus intravenous (IV) ascorbic acid 1g/kg 3 times/week and Arm B: pazopanib 800 mg daily.
SECONDARY OBJECTIVES:
I. To estimate and compare the overall survival (OS) in patients receiving pazopanib with or without IV ascorbic acid.
II. To estimate and compare the progression-free survival (PFS) in patients receiving pazopanib with or without IV ascorbic acid.
III. To estimate and compare the overall response rate (ORR) in patients receiving pazopanib with or without IV ascorbic acid.
IV. To estimate and compare the duration on pazopanib treatment in patients receiving pazopanib with or without IV ascorbic acid.
V. To assess the adverse events (AE) profile and safety of each treatment arm using the Common Terminology Criteria for Adverse Events (CTCAE).
CORRELATIVE RESEARCH:
I. Correlation between 5 mC, 5 hmC and H3K27me3 expression (as determined by immunohistochemistry [IHC]), as well as MeDIP/hMeDIP sequencing (seq), and response to combination of IV ascorbic acid and pazopanib.
II. Correlation between iron content in tumor microenvironment (as determined by Prussian blue staining) and response to combination of IV ascorbic acid and pazopanib combination.
III. Correlation between HIF-1alpha and HIF-2alpha expression (as determined by immunohistochemistry [IHC]) and response to combination of IV ascorbic acid and pazopanib combination.
IV. Correlation between GLUT1 expression (as determined by IHC) and response to combination of IV ascorbic acid and pazopanib.
V. Correlation between PDL1 expression (as determined by IHC) and response to combination of IV ascorbic acid and pazopanib.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 8 weeks for up to 2 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Total =\< 1.5 x (ULN) (obtained =\< 21 days prior to registration)
Individuals of non-, or individual of childbearing potential with negative serum pregnancy test =\< 7 days prior to randomization and willing to practice total abstinence or use a highly effective method of , as outlined below:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female individual who has had the following:
Agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
Exclusion Criteria:
Any of the following:
Uncontrolled intercurrent illness including, but not limited to:
gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
Treatment with any of the following anti-cancer therapies =\< 14 days prior to registration:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive pazopanib hydrochloride PO QD on days 1-28 and ascorbic acid IV three times per week. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Ascorbic Acid · Drug: Pazopanib Hydrochloride
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Pazopanib Hydrochloride
Given IV
Also known as: 2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one, Asorbicap, C Vitamin, C-Long, Ce-Vi-Sol, Cecon, Cenolate, Cetane, Cevalin, L-Ascorbic Acid, VIT C, Vitamin C, Vitamin-C
Given PO
Also known as: GW786034B, Votrient
Treatment Failure-free Rate
Treatment failure is defined as any of the following: radiographic disease progression, off-protocol treatment due to adverse event, initiation of alternative therapy (except metastasectomy post clinical benefit (complete response \[CR\], partial response \[PR\], or stable disease \[SD\] per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 to treatment), and death due to any cause.
Time frame: At 40 weeks
Overall Survival
Will be estimated using the method of Kaplan-Meier and be compared using log rank tests.
Time frame: 26 months
Progression Free Survival
Will be estimated using the Kaplan-Meier method.
Time frame: 16 Months
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan, PET/CT, or MRI: Complete Response (CR), Disappearance of all target lesions and all target lymph nodes must have reduction in short axis to \<1.0 cm; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation; Overall Response (OR) = CR + PR. Will be compared using a Chi-Square test.
Time frame: 16 Months
Duration of Time on Pazopanib Hydrochloride
Will be described as the median time on treatment by arm.
Time frame: 10 months
Frequency of Adverse Events
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events and toxicities will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event frequencies for grade 3 or higher adverse events, will be compared using Chi-Square tests between the 2 treatment arms.
Time frame: 10 Months
| Milestone | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Started | 2 | 3 |
| Completed | 1 | 3 |
| Not completed | 1 | 0 |
| Withdrew: Did not meet inclusion criteria | 1 | 0 |
Treatment failure is defined as any of the following: radiographic disease progression, off-protocol treatment due to adverse event, initiation of alternative therapy (except metastasectomy post clinical benefit (complete response \[CR\], partial response \[PR\], or stable disease \[SD\] per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 to treatment), and death due to any cause.
| Participants | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Treatment Failure-free Rate | 0 | 2 |
Will be estimated using the method of Kaplan-Meier and be compared using log rank tests.
| Months | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Overall Survival | 7.8 (NA to NA) | NA (NA to NA) |
Will be estimated using the Kaplan-Meier method.
| Months | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Progression Free Survival | 5.7 (5.7 to 5.7) | 11.8 (7.3 to 15.9) |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan, PET/CT, or MRI: Complete Response (CR), Disappearance of all target lesions and all target lymph nodes must have reduction in short axis to \<1.0 cm; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation; Overall Response (OR) = CR + PR. Will be compared using a Chi-Square test.
| Participants | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Overall Response Rate | 0 | 1 |
Will be described as the median time on treatment by arm.
| Months | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Duration of Time on Pazopanib Hydrochloride | 5.9 (5.9 to 5.9) | 9.2 (7.3 to 9.2) |
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events and toxicities will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event frequencies for grade 3 or higher adverse events, will be compared using Chi-Square tests between the 2 treatment arms.
| Participants | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Frequency of Adverse Events | 1 | 2 |
Collected over Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 10 months. All-Cause Mortality assessed up to 26 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Arm B (Pazopanib Hydrochloride) | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| Lung infectionInfections and infestations | 1/1 | 0/3 |
| FractureInjury, poisoning and procedural complications | 1/1 | 0/3 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/1 | 0/3 |
| Thromboembolic eventVascular disorders | 1/1 | 0/3 |
| Alanine aminotransferase increasedInvestigations | 0/1 | 1/3 |
| Event | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/1 | 3/3 |
| NauseaGastrointestinal disorders | 1/1 | 3/3 |
| FatigueGeneral disorders | 1/1 | 3/3 |
| Peripheral sensory neuropathyNervous system disorders | 1/1 | 1/3 |
| HypertensionVascular disorders | 1/1 | 3/3 |
| Mucositis oralGastrointestinal disorders | 0/1 | 2/3 |
| Alanine aminotransferase increasedInvestigations | 0/1 | 2/3 |
| Aspartate aminotransferase increasedInvestigations | 0/1 | 2/3 |
| Creatinine increasedInvestigations | 0/1 | 2/3 |
| AnemiaBlood and lymphatic system disorders | 0/1 | 1/3 |
| Age, Continuous(years) | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) | Total |
|---|---|---|---|
| Mean | 55 (55 to 55) | 56.7 (47.0 to 68.0) | 56.3 (47 to 68) |
| Sex: Female, Male(Participants) | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 3 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 3 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| MSKCC Risk Factor(Participants) | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | Arm B (Pazopanib Hydrochloride) | Total |
|---|---|---|---|
| Poor risk | 1 | 1 | 2 |
| Intermediate risk | 0 | 1 | 1 |
| Favorable risk | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Mar 2021, 36 months.
Results were first posted in Mar 2022, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ascorbic Acid
Academic and Community Cancer Research United