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Tyrosine Kinase Inhibitor

Sapanisertib for Peripheral Nerve Sheath Tumor

Phase 1 & 2
Waitlist Available
Led By William D Tap
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This study is evaluating whether a drug called sapanisertib and a drug called pazopanib hydrochloride are safe and effective in treating patients with sarcoma that is too large to be removed (locally advanced) or has spread to other areas of the body (metast

Eligible Conditions
  • Peripheral Nerve Sheath Tumor
  • Uterine Leiomyosarcoma
  • Leiomyosarcoma
  • Pleomorphic Sarcoma
  • Synovial Sarcoma
  • Sarcoma
  • Myxofibrosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period)
Secondary outcome measures
Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period)
Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period)
Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period)
+3 more
Other outcome measures
Cohort-specific Evaluation of 4-month Clinical Benefit Rate (CBR) (Phase II, Analysis Group II)
Duration of Response in Crossover Patients (Phase II)
Overall Survival (OS) in Crossover Patients (Phase II)
+2 more

Side effects data

From 2018 Phase 2 trial • 118 Patients • NCT02049957
100%
Nausea
83%
Stomatitis
67%
Fatigue
50%
Hyperglycaemia
50%
Dysgeusia
50%
Diarrhoea
50%
Pruritus
33%
Urinary tract infection
33%
Decreased appetite
33%
Arthralgia
33%
Weight decreased
33%
Aspartate aminotransferase increased
33%
Headache
33%
Alanine aminotransferase increased
33%
Dyspepsia
33%
Myalgia
17%
Sinusitis
17%
Drug reaction with eosinophilia and systemic symptoms
17%
Deafness neurosensory
17%
Proteinuria
17%
International normalised ratio increased
17%
Skin infection
17%
Hyponatraemia
17%
Pleurisy
17%
Ataxia
17%
Dehydration
17%
Hypoxia
17%
Rash maculo-papular
17%
Dry skin
17%
Eye pain
17%
Mental status changes
17%
Vomiting
17%
Pyrexia
17%
Blood creatinine increased
17%
Electrocardiogram QT prolonged
17%
Hypophosphataemia
17%
Hypercalcaemia
17%
Joint swelling
17%
Back pain
17%
Neck pain
17%
Dizziness
17%
Tremor
17%
Paraesthesia
17%
Hyperaesthesia
17%
Restless legs syndrome
17%
Serotonin syndrome
17%
Thrombosis in device
17%
Anxiety
17%
Constipation
17%
Hyperlipidaemia
17%
Sepsis
17%
Dyspnoea
17%
Blood alkaline phosphatase increased
17%
Cough
17%
Hypoaesthesia
17%
Rhinorrhoea
17%
Rash pruritic
17%
Palmar-plantar erythrodysaesthesia syndrome
17%
Pneumonia
17%
Dysuria
17%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane
Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant
Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane
Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant
Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane
Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)
Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Resistant)
Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)
Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (pazopanib hydrochloride)Experimental Treatment2 Interventions
Patients receive pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm I.
Group II: Arm I (sapanisertib)Experimental Treatment1 Intervention
Patients receive sapanisertib as in Phase I. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pazopanib
2012
Completed Phase 4
~1370
Pazopanib Hydrochloride
2009
Completed Phase 2
~820
Sapanisertib
2016
Completed Phase 2
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,516 Total Patients Enrolled
William D TapPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma
2015. "Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02601209.
~16 spots leftby Apr 2025
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