Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Participants' Pharmacodynamic (PD) Responses
Study Overview
Brief Summary
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.
Detailed Description
Study Drug:
Temsirolimus is designed to block the growth of cancer cells, which may cause the cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive temsirolimus by vein over about 60 minutes on Day 1.
You will be assigned to a dose level of temsirolimus based on when you join this study. Up to 5 dose levels of temsirolimus will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, until the drug is found to affect the enzyme that was tested for at screening.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy.
- •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.
- •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
- •Pregnant or lactating women.
- •Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- •Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated.
- •Patients who are less than 18 years of age.
Arms & Interventions
Temsirolimus
Starting dose 0.02 mg intravenous administered once.
Intervention: Temsirolimus (Drug)
Outcomes
Primary Outcomes
Participants' Pharmacodynamic (PD) Responses
Time Frame: Blood drawn at 4 hours (+/- 2 hours) after study drug
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).
Secondary Outcomes
No secondary outcomes reported