A Phase 2 interventional study of Selumetinib and Sirolimus in Malignant Peripheral Nerve Sheath Tumors and Neurofibromatosis 1, sponsored by Sarcoma Alliance for Research through Collaboration. Completed at 5 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Sarcoma Alliance for Research through Collaboration · Phase 2, Interventional, and Treatment
To determine the clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic neurofibromatosis type 1 (NF1) associated or sporadic MPNST.
I. Primary Objective
II. Secondary Objective(s)
Selumetinib will be given orally 50mg twice daily continuously and sirolimus will be given orally 4mg once daily with a cycle 1 day 1 loading dose of 12mg. One cycle will be 28 days. Patients will be able to remain on treatment as long as they do not experience progressive disease or unacceptable toxicity. Stage 1 will require 7 patients, with no further accrual if 0 of 7 respond. If 1 or greater of the 7 patients respond, accrual will continue until 21 patients have been enrolled.
98 studies on the registry are indexed under Neurofibrosarcoma; 23 are open to participants now.
This study's enrollment of 21 is below the median of 46 across 84 interventional studies indexed under Neurofibrosarcoma.
Browse Neurofibrosarcoma studies →Sarcoma Alliance for Research through Collaboration is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients who any known severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Cardiac conditions as follows:
Ophthalmological conditions as follows:
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 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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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).
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A Simon's two-stage phase 2 trial of MEK inhibitor selumetinib in combination with the mTOR inhibitor sirolimus to determine the safety and clinical benefit in patients with unresectable or metastatic MPNSTs. Both agents will be given orally on an empty stomach. Selumetinib will be given orally at a dose of 50mg twice daily continuously. Sirolimus will be given orally at a dose of 4mg once daily with a cycle 1 day 1 loading dose of 12mg. Each cycle will be considered 28 days.
Drug: Selumetinib · Drug: Sirolimus
Selumetinib (AZD6244) is an oral selective inhibitor of the mitogen-activated protein kinase (MEK) 1/2 currently in development for adult malignancies, pediatric low-grade gliomas and NF1 plexiform neurofibromas. MEK is a critical kinase in the mitogen activated protein (MAP) kinase signal transduction pathway for many growth factor receptors that provide growth signals to cancer cells.
Also known as: AZD6244
Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus and inhibitor of mammalian Target of Rapamycin (mTOR) serine threonine kinase, which plays a critical role in regulating cellular energy sensing, growth and metabolism.
Also known as: Rapamycin
Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
An evaluable patient will be classified as a responder if the patient achieves a partial response (PR), complete response (CR) or stable disease (SD) ≥ 4 cycles.
Time frame: Up to 6 months
Progression Free (PFS) and Overall Survival (OS)
Determined using the Kaplan-Meier method with PFS at important time points reported along with 95% two sided confidence intervals.
Time frame: PFS is the duration of time from the start of treatment to the time of objective progression or death whichever happens first up to 4 years. OS is the duration of time from the start of treatment to the time of death; assessed up to 4 years.
Define and Describe the Toxicities of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
Treatment-emergent adverse events occurring after initiation of selumetinib in combination with sirolimus were assessed and graded according to CTCAE v5.0. The safety population included all participants who received at least one dose of study treatment.
Time frame: Up to 6 months
Assess the Impact on Pain Interference
Change in Pain Interference (PROMIS) from baseline to pre-cycle 2 (calculated as the score pre-cycle 2 minus the score at baseline). Positive values indicate increasing pain. Higher scores indicate worse pain The statistical test assesses if there is a significant change in pain interference from baseline to pre-cycle 2 Wilcoxon signed-rank test T-scores are standardized to the general population with a mean of 50 and standard deviation of 10. Higher scores indicate worse anxiety symptoms. A T-score of 55-60 indicates mild pain interference, 60-70 indicates moderate pain interference, and 70-80 indicates severe pain interference.
Time frame: Up to 6 months
Assess the Impact on Pain Severity
Change in Pain Intensity, as assessed on the numerical rating scale 11, from baseline to pre-cycle 2 (calculated as the score pre-cycle 2 minus the score at baseline). Positive values indicate increasing pain. Higher scores indicate worse pain The statistical test assesses if there is a significant change in pain intensity from baseline to pre-cycle 2 Wilcoxon signed-rank test The Numerical Rating Scale-11 (NRS-11) is a self-report segmented 11-point numeric scale that assesses pain severity. It consists of a horizontal line with 0 representing "no pain" at the right end of the line and 10 representing "worst pain you can imagine" at the left end.
Time frame: Up to 6 months
| Milestone | Selumetinib and Sirolimus |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
An evaluable patient will be classified as a responder if the patient achieves a partial response (PR), complete response (CR) or stable disease (SD) ≥ 4 cycles.
| Proportion | Selumetinib and Sirolimus |
|---|---|
| Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST. | 0.095 (0.0167 to 0.32) |
Determined using the Kaplan-Meier method with PFS at important time points reported along with 95% two sided confidence intervals.
| Months | Selumetinib and Sirolimus |
|---|---|
| PFS | 1.97 (1.71 to 3.65) |
| OS | 6.12 (3.55 to 10.39) |
Treatment-emergent adverse events occurring after initiation of selumetinib in combination with sirolimus were assessed and graded according to CTCAE v5.0. The safety population included all participants who received at least one dose of study treatment.
| Participants | Selumetinib and Sirolimus |
|---|---|
| Infection, cecal — Grade 3 | 1 |
| Infection, cecal — Grade 4 | 0 |
| Infection, cecal — No Grade 3-4 AE reported | 20 |
| Anemia — Grade 3 | 1 |
| Anemia — Grade 4 | 0 |
| Anemia — No Grade 3-4 AE reported | 20 |
| Dyspnea — Grade 3 | 1 |
| Dyspnea — Grade 4 | 0 |
| Dyspnea — No Grade 3-4 AE reported | 20 |
| Hypertension — Grade 3 | 1 |
| Hypertension — Grade 4 | 0 |
| Hypertension — No Grade 3-4 AE reported | 20 |
| Hypokalemia — Grade 3 | 1 |
| Hypokalemia — Grade 4 | 0 |
| Hypokalemia — No Grade 3-4 AE reported | 20 |
| Hypoxia — Grade 3 | 1 |
| Hypoxia — Grade 4 | 0 |
| Hypoxia — No Grade 3-4 AE reported | 20 |
| Hypophosphatemia — Grade 3 | 0 |
| Hypophosphatemia — Grade 4 | 1 |
| Hypophosphatemia — No Grade 3-4 AE reported | 20 |
| Mucositis, oral — Grade 3 | 1 |
| Mucositis, oral — Grade 4 | 0 |
| Mucositis, oral — No Grade 3-4 AE reported | 20 |
| Pleural effusion — Grade 3 | 1 |
| Pleural effusion — Grade 4 | 0 |
| Pleural effusion — No Grade 3-4 AE reported | 20 |
Change in Pain Interference (PROMIS) from baseline to pre-cycle 2 (calculated as the score pre-cycle 2 minus the score at baseline). Positive values indicate increasing pain. Higher scores indicate worse pain The statistical test assesses if there is a significant change in pain interference from baseline to pre-cycle 2 Wilcoxon signed-rank test T-scores are standardized to the general population with a mean of 50 and standard deviation of 10. Higher scores indicate worse anxiety symptoms. A T-score of 55-60 indicates mild pain interference, 60-70 indicates moderate pain interference, and 70-80 indicates severe pain interference.
| PROMIS T-Score | Selumetinib and Sirolimus |
|---|---|
| Median at baseline | 61.5 (56.2 to 64.7) |
| Median pre Cycle 2 | 55.9 (52.5 to 61.3) |
Change in Pain Intensity, as assessed on the numerical rating scale 11, from baseline to pre-cycle 2 (calculated as the score pre-cycle 2 minus the score at baseline). Positive values indicate increasing pain. Higher scores indicate worse pain The statistical test assesses if there is a significant change in pain intensity from baseline to pre-cycle 2 Wilcoxon signed-rank test The Numerical Rating Scale-11 (NRS-11) is a self-report segmented 11-point numeric scale that assesses pain severity. It consists of a horizontal line with 0 representing "no pain" at the right end of the line and 10 representing "worst pain you can imagine" at the left end.
| Numerical Rating Scale-11 (NRS-11) score | Selumetinib and Sirolimus |
|---|---|
| Median at baseline | 6.0 (2.5 to 9.5) |
| Median pre Cycle 2 | 5.0 (2.5 to 6.5) |
Collected over All-cause mortality was monitored from enrollment until death or end of follow-up, up to 4 years. Serious and other adverse events were assessed from first study treatment through 30 days after the last treatment or until resolution or stabilization of the adverse event (whichever occurs last), up to 4 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Selumetinib and Sirolimus | 2/21 (9.5%) | 21/21 (100%) | 21/21 (100%) |
| Event | Selumetinib and Sirolimus |
|---|---|
| LYMPHOCYTE COUNT DECREASEDBlood and lymphatic system disorders | 5/21 |
| ANEMIABlood and lymphatic system disorders | 3/21 |
| ABDOMINAL PAINGastrointestinal disorders | 2/21 |
| HYPERTENSIONCardiac disorders | 2/21 |
| HYPOKALEMIAMetabolism and nutrition disorders | 2/21 |
| HYPOXIARespiratory, thoracic and mediastinal disorders | 2/21 |
| MULTI-ORGAN FAILUREGeneral disorders | 2/21 |
| URINARY TRACT INFECTIONInfections and infestations | 2/21 |
| ADMITTED FOR WOUND EROSION WITH POSSIBLE SUPERINFECTIONInfections and infestations | 1/21 |
| CECAL INFECTIONInfections and infestations | 1/21 |
| Event | Selumetinib and Sirolimus |
|---|---|
| NAUSEAGastrointestinal disorders | 12/21 |
| HYPOALBUMINEMIAMetabolism and nutrition disorders | 9/21 |
| RASH ACNEIFORMSkin and subcutaneous tissue disorders | 9/21 |
| HYPERGLYCEMIAMetabolism and nutrition disorders | 8/21 |
| ALKALINE PHOSPHATASE INCREASEDHepatobiliary disorders | 7/21 |
| ANEMIABlood and lymphatic system disorders | 7/21 |
| FATIGUEGeneral disorders | 7/21 |
| VOMITINGGastrointestinal disorders | 7/21 |
| EDEMA LIMBSGeneral disorders | 7/21 |
| ASPARTATE AMINOTRANSFERASE INCREASEDHepatobiliary disorders | 6/21 |
| Age, Categorical(Participants) | Selumetinib and Sirolimus |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 18 |
| >=65 years | 2 |
| Age, Continuous(years) | Selumetinib and Sirolimus |
|---|---|
| Median | 41 (16 to 72) |
| Sex: Female, Male(Participants) | Selumetinib and Sirolimus |
|---|---|
| Female | 7 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Selumetinib and Sirolimus |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Selumetinib and Sirolimus |
|---|---|
| United States | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: AZD 6244 · Sirolimus
Sarcoma Alliance for Research through Collaboration