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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
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
Study Summary
This trial is studying how well sapanisertib works in treating patients with bladder cancer that has spread to nearby tissue or lymph nodes with tuberous sclerosis mutations.
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.Check my eligibility
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.See study design
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 belowSelect...
My tumor has a TSC1 or TSC2 mutation, confirmed by a certified lab.
Select...
I am following the required contraceptive measures.
Select...
I can swallow pills.
Select...
My cancer is an advanced or spread bladder cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from start of treatment to time of death from any cause, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of treatment to time of death from any cause, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (TSC1 patients)
Secondary outcome measures
Incidence of toxicity (TSC1 patients)
Overall survival (OS) (TSC1 patients)
Progression-free survival (PFS) (TSC1 patients)
Other outcome measures
Incidence of toxicity (TSC2 patients)
Overall response rate (TSC2 patients)
Overall survival (TSC2 patients)
+1 moreSide effects data
From 2018 Phase 2 trial • 118 Patients • NCT02049957100%
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%
Skin infection
17%
Sinusitis
17%
Pleurisy
17%
Deafness neurosensory
17%
Proteinuria
17%
International normalised ratio increased
17%
Hyponatraemia
17%
Ataxia
17%
Dehydration
17%
Drug reaction with eosinophilia and systemic symptoms
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
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
13,687 Previous Clinical Trials
40,930,162 Total Patients Enrolled
Joseph W KimPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients must have a specific amount of disease that can be measured using a standard method.I have not had chemotherapy, immunotherapy, or experimental treatments recently.I have untreated brain metastases that are causing symptoms.I am HIV-positive and on combination antiretroviral therapy.I do not have serious heart or lung disease currently.I haven't had any specified events in the last 6 months.I am not taking strong medication that affects liver enzymes within a week before starting MLN0128.I have had radiation therapy in the last 4 weeks.You have a prolonged rate-corrected QT interval.I have an active hepatitis B or C infection that hasn't been treated.I started bisphosphonates less than 30 days before starting MLN0128.You have had allergic reactions to drugs similar to MLN0128 (TAK-228).My tumor has a TSC1 or TSC2 mutation, confirmed by a certified lab.My cancer worsened within a year after receiving platinum-based treatment.My diabetes is under control.I am following the required birth control measures.I am following the required contraceptive measures.I can swallow pills.I have previously taken PI3K, AKT, or mTOR inhibitors.My cancer progressed after platinum treatment or I can't have cisplatin.I am taking medication for brain cancer that has spread.I cannot receive cisplatin-based chemotherapy due to certain health reasons.My cancer is an advanced or spread bladder cancer.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sapanisertib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other experiments have been undertaken to establish the efficacy of Sapanisertib?
"Currently, 11 Sapanisertib research studies are running. None of those trials have reached Phase 3 yet and the majority of them are located in Boston, Massachusetts with a total of 1934 sites across the world participating in clinical trials for this medication."
Answered by AI
Has Sapanisertib attained official sanction from the FDA?
"The safety of Sapanisertib is estimated to be a 2, as Phase 2 trials provide preliminary evidence that the drug may not pose an unwarranted risk but lack any data pointing towards its efficacy."
Answered by AI
What is the scope of this clinical trial in terms of participant sites?
"This clinical trial has 22 different enrolment sites, including the University of California Davis Comprehensive Cancer Center in Sacramento, UPCI situated in Pittsburgh, and Vanderbilt University/Ingram Cancer Center located in Nashville. Additionally, there are 19 other locations extending across the United States."
Answered by AI
Are there still slots available to participate in this trial?
"Clinicaltrials.gov records reveal that this research is no longer recruiting new participants, as it was originally posted December 1st 2016 and most recently edited on September 20th 2022. Despite this, there are several other clinical trials actively accepting patients at the moment; at least 2736 to be exact!"
Answered by AI
How many participants are taking part in this clinical trial?
"Unfortunately, recruitment for this trial has been ceased. The medical study was initially published on December 1st 2016 and the last edit occurred September 20th 2022. However, those in search of clinical trials can reference 2725 studies recruiting participants with carcinoma or transitional cell cancer as well as 11 Sapanisertib trials actively seeking candidates."
Answered by AI
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