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NCT03298958
Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
Phase 3 trial testing Rapamycin in Bladder Cancer. Withdrawn.
1 February 2022
Quick facts
| Lead sponsor | The University of Texas Health Science Center at San Antonio |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 November 2018 |
| Primary completion | 1 February 2022 |
| Estimated completion | 1 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rapamycin — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Bladder Cancer — all drugs for Bladder Cancer →
Sponsor
The University of Texas Health Science Center at San Antonio
Who can join
18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Inhibitors of the PI3K/AKT/mTOR pathway in human malignancies; trend of current clinical trials.
Davoodi-Moghaddam Z, Jafari-Raddani F, Delshad M, Pourbagheri-Sigaroodi A, et al · · 2023 · cited 14× · PMID 37594532 · DOI 10.1007/s00432-023-05277-x
Verify or expand the search:
- PubMed search for NCT03298958
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rapamycin
Trials testing the same drug.
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- NCT06550271 — The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals · completed
- NCT05342519 — Daily Topical Rapamycin for Vitiligo · Phase 2 · active not recruiting
- NCT04736589 — Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway · Phase 3 · not yet recruiting
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
- NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
- NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
- NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting
Other The University of Texas Health Science Center at San Antonio trials
Trials by the same sponsor.
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- NCT07056699 — SGLT2i, Pioglitazone, and Ketone Production in T1D · Phase 3 · not yet recruiting
- NCT06609343 — Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis · Phase 1, PHASE2 · not yet recruiting
- NCT07437053 — Sarcopenia in Chronic Kidney Disease (CKD) Patients · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03298958 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio
- Last refreshed: 12 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03298958.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing