Trial · NCT03047213
Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
NCT03047213, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations. Trials, record NCT03047213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03047213
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
- NCT number
- NCT03047213
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Locally Advanced Bladder Urothelial Carcinoma, Metastatic Transitional Cell Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Bladder Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
- Interventions
- Sapanisertib
- First posted
- 2017-02-08
- Last updated
- 2026-07-31
- Results first posted
- 2025-02-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (TSC1 Patients) | Up to 4 weeks after last dose of study treatment (approximately 19 weeks) | Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response Rate is the proportion of the patients with either complete response (CR) or partial response (PR) by Response Evaluation Criteria. In Solid Tumors Criteria (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target lesions and partial response (PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Incidence of Toxicity (TSC1 Patients) | Up to 4 weeks after last dose of study treatment (approximately 19 weeks) | Presented are the most frequently occurring adverse events (25% of patients or greater) |
| Secondary | Progression-free Survival (PFS) (TSC1 Patients) | Time from start of treatment to date of progression or death- (approximately 19 weeks) | The censored PFS distributions will each be estimated by the Kaplan-Meier (K-M) survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc. Upon results entry, no patients had reached 6 or 12 months PFS and the outcome and timeframe have been updated. Progression-free survival (PFS) is defined as the duration of time from start of treatment to date of progression or death, whichever occurs first. Progression by RECIST v1.1 criteria is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Overall Survival (OS) (TSC1 Patients) | Time from start of treatment to time of death from any cause, up to approximately 9 months | The censored OS distributions will each be estimated by the K-M survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc. |
| Other | Overall Response Rate (TSC2 Patients) | Up to 4 weeks after last dose of study treatment (approximately 19 weeks) | |
| Other | Incidence of Toxicity (TSC2 Patients) | Up to 4 weeks after last dose of study treatment | The occurrence rate of each specific type of toxicity at a certain severity grade will be described by point estimates and Wilson type 90% (2-sided) CIs. |
| Other | Progression-free Survival (TSC2 Patients) | Time from start of treatment to date of progression or death, whichever occurs first, assessed up to 1 year | The censored PFS distributions will each be estimated by the K-M survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc. |
| Other | Overall Survival (TSC2 Patients) | Time from start of treatment to time of death from any cause, assessed up to 1 year | The censored OS distributions will each be estimated by the K-M survivorship function. Point estimates and 90% (2-sided) CIs will be computed for all estimable summary statistics, e.g., the median, 6-month rate, 12-month rate, etc. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (TSC1 Patients) | Up to 4 weeks after last dose of study treatment (approximately 19 weeks) | 12 of 14 patients were evaluable for the outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Toxicity (TSC1 Patients) | Up to 4 weeks after last dose of study treatment (approximately 19 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) (TSC1 Patients) | Time from start of treatment to date of progression or death- (approximately 19 weeks) | 12 of 14 patients were evaluable | days | MEDIAN |
| SECONDARY | Overall Survival (OS) (TSC1 Patients) | Time from start of treatment to time of death from any cause, up to approximately 9 months | 12 of 14 patients were evaluable | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Overall Response Rate (TSC2 Patients) | Up to 4 weeks after last dose of study treatment (approximately 19 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Incidence of Toxicity (TSC2 Patients) | Up to 4 weeks after last dose of study treatment | |||
| OTHER_PRE_SPECIFIED | Progression-free Survival (TSC2 Patients) | Time from start of treatment to date of progression or death, whichever occurs first, assessed up to 1 year | |||
| OTHER_PRE_SPECIFIED | Overall Survival (TSC2 Patients) | Time from start of treatment to time of death from any cause, assessed up to 1 year |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | 0 | Participants | ||
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | Hyperglycemia | 11 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | Creatinine increased | 7 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | Hypoalbuminemia | 7 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | Anemia | 6 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | AST increased | 5 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | diarrhea | 5 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | lymphocyte count decreased | 5 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | rash | 5 | Participants | |
| Incidence of Toxicity (TSC1 Patients) | Treatment (Sapanisertib): TSC Mutation 1 | Alkaline phosphatase increased | 4 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Sapanisertib): TSC Mutation 1 | 14 | |
| Overall Study | STARTED | TSC Mutation 2 | 3 | |
| Overall Study | COMPLETED | Treatment (Sapanisertib): TSC Mutation 1 | 10 | |
| Overall Study | COMPLETED | TSC Mutation 2 | 3 | |
| Overall Study | NOT COMPLETED | Treatment (Sapanisertib): TSC Mutation 1 | 4 | |
| Overall Study | NOT COMPLETED | TSC Mutation 2 | 0 |
Source ClinicalTrials.gov
Adverse events184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Sapanisertib): TSC Mutation 1 | 3 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | TSC Mutation 2 | 0 | 3 | |
| other | Activated PTT prolonged | Investigations | Treatment (Sapanisertib): TSC Mutation 1 | 1 | 12 | |
| other | Activated PTT prolonged | Investigations | TSC Mutation 2 | 0 | 3 | |
| other | AKI | Renal and urinary disorders | Treatment (Sapanisertib): TSC Mutation 1 | 2 | 12 | |
| other | AKI | Renal and urinary disorders | TSC Mutation 2 | 0 | 3 | |
| other | Alkaline phosphatase increased | Hepatobiliary disorders | Treatment (Sapanisertib): TSC Mutation 1 | 4 | 12 | |
| other | Alkaline phosphatase increased | Hepatobiliary disorders | TSC Mutation 2 | 1 | 3 | |
| other | ALT increased | Hepatobiliary disorders | Treatment (Sapanisertib): TSC Mutation 1 | 1 | 12 | |
| other | ALT increased | Hepatobiliary disorders | TSC Mutation 2 | 2 | 3 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Sapanisertib): TSC Mutation 1 | 10 | 12 |
| Total, all-cause mortality | TSC Mutation 2 | 3 | 3 |
| Total, other adverse events | Treatment (Sapanisertib): TSC Mutation 1 | 12 | 12 |
| Total, other adverse events | TSC Mutation 2 | 3 | 3 |
| Total, serious adverse events | Treatment (Sapanisertib): TSC Mutation 1 | 6 | 12 |
| Total, serious adverse events | TSC Mutation 2 | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Sapanisertib): TSC Mutation 1 vs TSC Mutation 2: deaths from any cause | Trial comparisons |
| Treatment (Sapanisertib): TSC Mutation 1 vs TSC Mutation 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03047213
GET https://conductscience.org/api/trials/v1/NCT03047213/results?page=2