Phase 2
Completed N=54
Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Source: ClinicalTrials.gov NCT01827943 ↗Enrolled (actual)
54
Serious AEs
66.0%
Results posted
Apr 2021
Primary outcomePrimary: Non-progression Rate at 2 Months — 48.9 percentage of participants
Summary
In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-progression Rate at 2 Months |
48.9 | — |
| SECONDARY Overall Survival |
7.2 | — |
| SECONDARY Progression-free Survival |
2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women of at least 18 years of age
- Histologically proven Bladder cancer
- Locally advanced or metastatic disease (stage IV)
- Functional status (ECOG / OMS) ≤ 2
- Relapse after first-line chemotherapy
- Measurable lesions (RECIST criteria)
- Absence of anti-neoplasic treatment in the 4 weeks preceding inclusion.
- Biological levels :
- Neutrophil count >1,5.109/L.
- Platelets >100.109/L
- Total serum bilirubin < 1.5 × ULN
- Clearance of créatinine 40 ml/mm
- If not liver metastasis alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN
- With liver alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN
- Signed informed consent
- Both women and men must agree to use a medically acceptable method of contraception throughout the study. Women of childbearing potential must have a negative serum pregnancy test of or less than 7 days before the first perfusion of study.
- France only : Patients affiliated to a social security program
Exclusion Criteria
- Presence of metastatic brain or meningeal tumors on selection scanner, weither symptomatic or asymptomatic
- Chemotherapy, immunotherapy, or radiotherapy within 4 weeks of inclusion
- Known hypersensitivity to temsirolimus, or its metabolites (as sirolimus), or polysorbate 80 or to their excipients
- Previous malignancy (except for cervical carcinoma in situ, basal cell carcinoma curatively treated) or incidental (≤ pT2) prostate cancer found on a radical cystoprostatectomy material
- The drugs known as CYP3A4/5 inhibitors or inducers will specifically be excluded on the 30th day ( or at least 7 halves-lives, according to the shortest duration) before the first perfusion and throughout the study. Any food known to inhibit CYP3A4/5 (for example grapefruit, grapefruit juice, star-fruit or star-fruit juice) will also be purposely excluded.
- Auto-immune pathology, psychiatric or neurological disorder
- Any unstable medical condition
- Unstable cardiac disease
- Severe renal failure
- Unstable diabetes
- Pregnancy
- Patient enrolled in another therapeutic clinical trial
- Patient unable to follow and comply with the study procedures because of any geographical, social or medical condition
- Patient partially or totally deprived of his civil rights
Data sourced from ClinicalTrials.gov (NCT01827943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.