Temsirolimus In Phase 0

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01417065
First received: August 12, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Drug: Temsirolimus
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participants' Pharmacodynamic (PD) Responses [ Time Frame: Blood drawn at 4 hours (+/- 2 hours) after study drug ] [ Designated as safety issue: No ]
    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).


Enrollment: 15
Study Start Date: August 2010
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus
Starting dose 0.02 mg intravenous administered once.
Drug: Temsirolimus
Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.
Other Names:
  • CCI-779
  • Torisel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417065

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Daniel Karp, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01417065     History of Changes
Other Study ID Numbers: 2010-0259, NCI-2011-02799, 2 K12 CA088084 12
Study First Received: August 12, 2011
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
mTOR inhibitor Temsirolimus
Torisel
CCI-779
pharmacodynamic targets

Additional relevant MeSH terms:
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014