ClinicalTrials.gg
CompletedNCT01462630Updated Aug 19, 2022Results posted

Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

A Phase 2 interventional study of pazopanib hydrochloride and laboratory biomarker analysis in Adult Angiosarcoma, Recurrent Adult Soft Tissue Sarcoma and Stage III Adult Soft Tissue Sarcoma, sponsored by Fox Chase Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.

Sponsored by Fox Chase Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the progression free survival (PFS) at 3 months and response rate defined as complete response (CR) and partial response (PR) in angiosarcoma patients treated with pazopanib.

SECONDARY OBJECTIVES:

I. To assess overall survival of patients treated with pazopanib. II. To gather more safety data for pazopanib in this patient population. III. To explore the ability of [F-18] fludeoxyglucose (FDG) (positron emission tomography [PET])/computed tomography (CT) imaging to assess response.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

02

Conditions studied

  • Adult Angiosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
03

In context

Hemangiosarcoma

99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.

This study's enrollment of 29 is below the median of 64 across 83 interventional studies indexed under Hemangiosarcoma.

Browse Hemangiosarcoma studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 216 studies on the registry; 29 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Subjects must provide written and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up

    • Note: informed consent may be obtained prior to start of the specified screening window
    • Note: procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
  • or cytologically proven diagnosis of advanced stage angiosarcoma that is not amenable to treatment with curative intent; specify site of origin as cutaneous vs. non-cutaneous
  • (ECOG) performance status of =\< 2
  • Must have per (RECIST) 1.1 or cutaneous disease amenable to serial measurements should be present; a measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter >= 10 mm with computed tomography (CT) scan; lesions that have been treated with therapeutic intent will be considered measurable if they have increased in size by more than 20%
  • (ANC) >= 1.5 X 10\^9/L
  • >= 9 g/dL (5.6 mmol/L)
  • >= 100 X 10\^9/L
  • (INR) =\< 1.2 X (ULN)
  • Activated partial thromboplastin time (aPTT) =\< 1.2 X ULN
  • Total =\< 1.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
  • Alanine amino transferase () and aspartate aminotransferase (AST) =\< 2.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
  • Serum creatinine =\< 1.5 mg/dL (133 umol/L)
  • Or, if serum creatinine > 1.5 mg/dL: calculated (ClCR) > 50 mL/min
  • Urine Protein to Creatinine Ratio (UPC) \< 1
  • Able to swallow pills whole and retain oral medication
  • A female is eligible to enter and participate in this study if the following apply:
  • Non- (i.e., physiologically incapable of becoming pregnant), including any female who has had:

    • A hysterectomy
    • A bilateral oophorectomy (ovariectomy)
    • A bilateral tubal ligation
    • Is
  • Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value \< 40pg/mL (\< 140 pmol/L)
  • Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment and for 3 months after the completion of treatment, preferably as close to the first dose as possible, and agrees to use adequate ; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:

    • Complete abstinence from sexual intercourse for 14 days before exposure to product, through the dosing period, and for at least 21 days after the last dose of investigational product
    • Oral contraceptive, either combined or progestogen alone
    • Injectable progestogen
    • Implants of levonorgestrel
    • Estrogenic vaginal ring
    • Percutaneous contraceptive patches
    • Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
    • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
    • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
  • A male is eligible to enter and participate in this study if he and his female sexual partner in the reproductive age group agree to use effective methods of contraception

Exclusion criteria

Exclusion Criteria:

  • Prior :

Subjects with a history of a prior malignancy other than angiosarcoma who have been disease-free for at least 2 years prior to the first dose of study drug and/or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible

  • History or clinical evidence of central nervous system (CNS) or , except for individuals who have previously-treated , are asymptomatic, and have had no requirement for or anti-seizure medications for 3 months prior to first dose of study drug; screening with CNS imaging studies (CT or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases
  • gastrointestinal (GI) abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:

    • Active peptic ulcer disease
    • Known intraluminal metastatic lesion/s with risk of bleeding
    • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
    • Clinically significant (> 1/2 teaspoon) hemoptysis or gastrointestinal hemorrhage in the past 6 months
  • Evidence of active bleeding or bleeding diathesis; recent hemoptysis (>= 1/2 teaspoon of red blood within 8 weeks before first dose of study drug)
  • Clinically significant gastrointestinal abnormalities that may affect absorption of product including, but not limited to:

    • Malabsorption syndrome
    • Major resection of the stomach or small bowel
  • interval (QTc) > 480 msecs using Bazett's formula
  • \< 50%
  • History of any one or more of the following cardiovascular conditions within the past 6 months:

    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery
    • Symptomatic peripheral vascular disease
    • Class III or IV congestive heart failure, as defined by the (NYHA)
  • Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP / DBP ratio must be \< 140/90 mmHg in order for a subject to be eligible for the study
  • Cerebrovascular accident including (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months

    • Note: subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks are eligible
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
  • Evidence of active bleeding or bleeding diathesis; recent hemoptysis (>= ½ teaspoon of red blood within 8 weeks before first dose of study drug)
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels (Note: tumor abutting the vessel is acceptable, but contiguous tumor and vessel is not; CT with contrast is strongly recommended to evaluate such lesions)
  • Abnormal serum calcium, magnesium, or potassium levels
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of , or compliance to study procedures
  • Use of any prohibited medication within the timeframes
  • Treatment with any of the following therapies:

    • Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib hydrochloride OR
    • Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
    • Patients who require chronic use of strong cytochrome P450 3A4 () inhibitors or inducers including but not limited to grapefruit juice
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 (except value) and/or that is progressing in severity, except alopecia
  • Previous exposure to pazopanib hydrochloride or a vascular endothelial growth factor receptor (VEGFR) targeted kinase therapy, except for bevacizumab or VEGFR-Trap (Aflibercept)
  • Known immediate or delayed reaction or idiosyncrasy to drugs chemically related to pazopanib
Terms in these criteria, in plain language(29)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

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.

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Treatment (enzyme inhibitor therapy)

    Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

    Drug: pazopanib hydrochloride · Other: laboratory biomarker analysis · Procedure: positron emission tomography · Procedure: computed tomography · Radiation: fludeoxyglucose F 18

Interventions

  • Given PO

    Also known as: GW786034B, Votrient

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Procedurepositron emission tomography

    Correlative studies

    Also known as: FDG-PET, PET, PET scan, tomography, emission computed

  • Procedurecomputed tomography

    Correlative studies

    Also known as: tomography, computed

  • Radiationfludeoxyglucose F 18

    Correlative studies

    Also known as: 18FDG, FDG

06

What researchers measure

Primary outcomes

  1. PFS Rate

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was estimated using the method of Kaplan and Meier.

    Time frame: 3 months

  2. Response Rate Defined as CR

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

    Time frame: 3 months

  3. Response Rate Defined as Partial Response (PR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

    Time frame: 3 months

Secondary outcomes

  1. Overall Survival of Patients Treated With Pazopanib Hydrochloride

    Estimated using the method of Kaplan and Meier.

    Time frame: Up to 107 weeks

  2. Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population

    Toxicities related/unrelated to study treatment with \>10% frequency

    Time frame: Up to 2 years

  3. Ability of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging

    Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented.

    Time frame: Up to 2 years

07

Results

Posted Aug 19, 2022

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Enzyme Inhibitor Therapy)
Started29
Completed22
Not completed7
Withdrew: Did not initiate therapy3
Withdrew: Death1
Withdrew: Protocol violation2
Withdrew: Adverse event1

Outcome measures

PrimaryPFS Rate

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was estimated using the method of Kaplan and Meier.

Time frame:
3 months
Reported as:
Number · percentage of patients
PFS Rate
percentage of patientsTreatment (Enzyme Inhibitor Therapy)
PFS Rate54.6 (36.0 to 82.9)
PrimaryResponse Rate Defined as CR

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

Time frame:
3 months
Reported as:
Count of participants · Participants
Response Rate Defined as CR
ParticipantsTreatment (Enzyme Inhibitor Therapy)
Response Rate Defined as CR0
PrimaryResponse Rate Defined as Partial Response (PR)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

Time frame:
3 months
Reported as:
Count of participants · Participants
Response Rate Defined as Partial Response (PR)
ParticipantsTreatment (Enzyme Inhibitor Therapy)
Response Rate Defined as Partial Response (PR)1
SecondaryOverall Survival of Patients Treated With Pazopanib Hydrochloride

Estimated using the method of Kaplan and Meier.

Time frame:
Up to 107 weeks
Reported as:
Median · weeks
Overall Survival of Patients Treated With Pazopanib Hydrochloride
weeksTreatment (Enzyme Inhibitor Therapy)
Overall Survival of Patients Treated With Pazopanib Hydrochloride69.8 (42.3 to 106.7)
SecondaryEvaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population

Toxicities related/unrelated to study treatment with \>10% frequency

Time frame:
Up to 2 years
Reported as:
Number · toxicities
Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population
toxicitiesTreatment (Enzyme Inhibitor Therapy)
Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population189
SecondaryAbility of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging

Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented.

Time frame:
Up to 2 years

No measurements were reported for this outcome.

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Enzyme Inhibitor Therapy)1/29 (3.4%)13/29 (44.8%)29/29 (100%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventTreatment (Enzyme Inhibitor Therapy)
alanine aminotransferase increaseInvestigations4/29
Bilirubin increaseInvestigations2/29
Aspartate aminotransferase increaseInvestigations2/29
abdominal painGastrointestinal disorders2/29
pericardial effusionCardiac disorders2/29
anemiaBlood and lymphatic system disorders1/29
low plateletBlood and lymphatic system disorders1/29
Urinary tract infectionRenal and urinary disorders1/29
DeathGeneral disorders1/29
edemaGeneral disorders1/29
Most frequent other events
Showing 10 of 62
Most frequent other events
EventTreatment (Enzyme Inhibitor Therapy)
FatigueGeneral disorders18/29
HypertensionVascular disorders14/29
NauseaGastrointestinal disorders14/29
PainGeneral disorders14/29
HeadacheNervous system disorders14/29
DiarrheaGastrointestinal disorders13/29
TransaminitisInvestigations13/29
VomitingGastrointestinal disorders10/29
SGOT increaseInvestigations10/29
SGPT increaseInvestigations10/29

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Enzyme Inhibitor Therapy)
Median66 (30 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Enzyme Inhibitor Therapy)
Female17
Male12
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Enzyme Inhibitor Therapy)
Hispanic or Latino1
Not Hispanic or Latino25
Unknown or Not Reported3
Region of Enrollment
Region of Enrollment(Participants)Treatment (Enzyme Inhibitor Therapy)
United States29
08

Study locations

5 sites
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111-2497, United States
  • Hollings Cancer Center Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2011 to primary completion in Jan 2019, 85 months.

Results were first posted in Aug 2022, 3 years 7 months after primary completion.

Of 28 phase 2 interventional studies under Hemangiosarcoma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 91. This study's 85 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2011
First posted
Oct 31, 2011
StartActual
Nov 3, 2011
Primary completionActual
Jan 2, 2019
CompletionActual
Jan 12, 2021
Results first posted
Aug 19, 2022
Last update
Aug 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01462630
Responsible party
Sponsor
First posted
Oct 31, 2011
Start date
Nov 3, 2011
Primary completion
Jan 2, 2019
Completion
Jan 12, 2021
Results posted
Aug 19, 2022
Last update
Aug 19, 2022

Study contacts

Margaret von Mehren
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pazopanib

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