Clinical trial · Interventional
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
NCT00877773CI-TRIAL-00023638terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temsirolimus
- description
- Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
- interventionNames
- Drug: Temsirolimus
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- Baseline to Disease Progression (restaged at 8 weeks and at 4 months)
- description
- For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease). 2. Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss. 3. Patients must have creatinine \</= 3 X upper limit of normal (ULN); absolute neutrophil count \>/= 1,000/mL; platelets \>/= 50,000; bilirubin \</= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin \</= 5 ULN. 4. Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study. 5. Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic therapies, patients should be off treatment for 3 or more weeks. 6. Patients may not be receiving any other experimental agents that are not FDA approved. 7. Ability to understand and willingness to sign a written consent document. 8. Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with creatinine clearance \<10 mL/min 3. Patients with a known hypersensitivity to any of the components or metabolites of the drug products. 4. Patients with major surgery within 30 days prior to entering study. 5. Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
References
Publications (0)
Data not yet available
No reference posted for this study.