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Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients

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: NCT00877773
Recruitment Status : Terminated (Slow Accrual)
First Posted : April 8, 2009
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Temsirolimus Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
Study Start Date : April 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Temsirolimus
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
Drug: Temsirolimus
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
Other Names:
  • CCI-779
  • Torisel

Primary Outcome Measures :
  1. Tumor Response [ Time Frame: Baseline to Disease Progression (restaged at 8 weeks and at 4 months) ]
    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).

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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00877773

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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
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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: NCT00877773    
Other Study ID Numbers: 2008-0827
NCI-2012-01265 ( Registry Identifier: NCI CTRP )
First Posted: April 8, 2009    Key Record Dates
Results First Posted: August 25, 2016
Last Update Posted: August 25, 2016
Last Verified: July 2016
Keywords provided by M.D. Anderson Cancer Center:
Advanced cancer
Advanced Cancer with genetic mutation
Phosphoinositides 3-kinase
PIK3 mutations
mTOR inhibitor
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