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Temsirolimus In Phase 0

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01417065
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : June 23, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Temsirolimus Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets
Study Start Date : August 2010
Actual Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01417065

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Daniel Karp, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01417065    
Other Study ID Numbers: 2010-0259
NCI-2011-02799 ( Registry Identifier: NCI CTRP )
2K12CA088084-12 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by M.D. Anderson Cancer Center:
mTOR inhibitor Temsirolimus
pharmacodynamic targets
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs