NCT00877773

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

July 1, 2016

Enrollment Period

5.2 years

First QC Date

April 7, 2009

Results QC Date

July 15, 2016

Last Update Submit

July 15, 2016

Conditions

Advanced Cancers

Keywords

Advanced cancerAdvanced Cancer with genetic mutationPhosphoinositides 3-kinasePI3KPIK3 mutationsTemsirolimusCCI-779ToriselmTOR inhibitor

Outcome Measures

Primary Outcomes (1)

  • Tumor Response

    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).

    Baseline to Disease Progression (restaged at 8 weeks and at 4 months)

Study Arms (1)

Temsirolimus

EXPERIMENTAL

Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.

Drug: Temsirolimus

Interventions

TemsirolimusDRUG

25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.

Also known as: CCI-779, Torisel
Temsirolimus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
  • 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.
  • 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.
  • 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.
  • Patients may not be receiving any other experimental agents that are not FDA approved.
  • Ability to understand and willingness to sign a written consent document.
  • Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.

You may not qualify if:

  • Pregnant or lactating women.
  • Patients with creatinine clearance \<10 mL/min
  • Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
  • Patients with major surgery within 30 days prior to entering study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

temsirolimus

Results Point of Contact

Title
Daniel Karp, MD / Professor, Investigational Cancer Therapeutics
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Daniel Karp, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 25, 2016

Results First Posted

August 25, 2016

Record last verified: 2016-07

Locations

US(1)