Clinical trial · Interventional
Temsirolimus In Phase 0
Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested. The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.
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 Cancer | 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
- Starting dose 0.02 mg intravenous administered once.
- interventionNames
- Drug: Temsirolimus
Primary outcomes (1)
- measure
- Participants' Pharmacodynamic (PD) Responses
- timeFrame
- Blood drawn at 4 hours (+/- 2 hours) after study drug
- description
- PD response, significant S6 Kinase 1 (S6K1) inhibition, is defined at both the patient level and the dose level, 1) as compared with baseline, at least 50% reductions of S6K1 after treatment (biological criterion); 2) differences in log transformed S6K1 activity between post-treatment and baseline should be greater than threshold of 1.8 times standard deviation (SD) of baseline, which yields a 90% statistical confidence that it is not due to chance variation (statistical criterion).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy. 2. Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, antibody or other biological therapy, whichever is shorter. 3. Patients should preferably be undergoing screening for 2007-0668, 2008-0384, 2008-0425, and 2008-0827 (currently active Phase I trials involving temsirolimus). However, patients may also be allowed on protocol if they are undergoing screening for any study. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with a known hypersensitivity to any of the components or metabolites of the drug products. 3. Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated. 4. Patients who are less than 18 years of age.
References
Publications (0)
Data not yet available