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mTOR inhibitor

Sapanisertib for Bladder Cancer

Phase 2
Waitlist Available
Led By Joseph W Kim
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
Patient must have TCCs tumors harboring a TSC1 or TSC2 mutation identified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
Male patients must meet specific contraceptive requirements
Must not have
Patients with known symptomatic, untreated central nervous system (CNS) metastasis
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of treatment to time of death from any cause, assessed up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how well sapanisertib works in treating patients with advanced or metastatic bladder cancer that have specific genetic mutations. Sapanisertib is taken by mouth and aims to stop cancer cell growth by blocking necessary enzymes.

Who is the study for?
This trial is for adults with advanced or metastatic bladder cancer that has specific genetic mutations (TSC1/TSC2). Participants must have had progression after platinum-based chemotherapy, be unfit for such treatment, or have recurred within 12 months of neoadjuvant/adjuvant therapy. They should not have received certain recent treatments and must be able to take oral medication and sign consent.
What is being tested?
The trial tests Sapanisertib's effectiveness on bladder cancer with TSC1/TSC2 mutations. It's a phase II study to see if the drug can halt tumor growth by inhibiting enzymes needed for cell proliferation. Patients will receive Sapanisertib orally to assess its impact on their disease.
What are the potential side effects?
While specific side effects of Sapanisertib are not listed here, similar drugs often cause fatigue, nausea, diarrhea, blood sugar changes (for those with diabetes), rash, and may affect liver function. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has a TSC1 or TSC2 mutation, confirmed by a certified lab.
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I am following the required contraceptive measures.
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I can swallow pills.
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My cancer is an advanced or spread bladder cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have untreated brain metastases that are causing symptoms.
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I am HIV-positive and on combination antiretroviral therapy.
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I do not have serious heart or lung disease currently.
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I have previously taken PI3K, AKT, or mTOR inhibitors.
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I have had radiation therapy in the last 4 weeks.
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I have an active hepatitis B or C infection that hasn't been treated.
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I am taking medication for brain cancer that has spread.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of treatment to time of death from any cause, assessed up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of treatment to time of death from any cause, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of toxicity (TSC1 patients)
Overall survival (OS) (TSC1 patients)
Progression-free survival (PFS) (TSC1 patients)
Other study objectives
Incidence of toxicity (TSC2 patients)
Overall survival (TSC2 patients)
Progression-free survival (TSC2 patients)

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%
Decreased appetite
33%
Urinary tract infection
33%
Arthralgia
33%
Weight decreased
33%
Aspartate aminotransferase increased
33%
Headache
33%
Alanine aminotransferase increased
33%
Dyspepsia
33%
Myalgia
17%
Restless legs syndrome
17%
Hypoxia
17%
Dizziness
17%
Tremor
17%
Hyponatraemia
17%
Dry skin
17%
Mental status changes
17%
Paraesthesia
17%
Sinusitis
17%
Skin infection
17%
Pyrexia
17%
Dehydration
17%
Deafness neurosensory
17%
Drug reaction with eosinophilia and systemic symptoms
17%
Vomiting
17%
Ataxia
17%
International normalised ratio increased
17%
Proteinuria
17%
Rash maculo-papular
17%
Pleurisy
17%
Eye pain
17%
Blood creatinine increased
17%
Electrocardiogram QT prolonged
17%
Hypophosphataemia
17%
Hypercalcaemia
17%
Joint swelling
17%
Back pain
17%
Neck pain
17%
Hyperaesthesia
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sapanisertib)Experimental Treatment1 Intervention
Patients receive sapanisertib PO QD on days 1-28. 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
Sapanisertib
2016
Completed Phase 2
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,011,935 Total Patients Enrolled
Joseph W KimPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
212 Total Patients Enrolled

Media Library

Sapanisertib (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03047213 — Phase 2
Bladder Cancer Research Study Groups: Treatment (sapanisertib)
Bladder Cancer Clinical Trial 2023: Sapanisertib Highlights & Side Effects. Trial Name: NCT03047213 — Phase 2
Sapanisertib (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03047213 — Phase 2
~26 spots leftby Nov 2025
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