A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01420081
First received: August 17, 2011
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Neoplasms |
Drug: PF-05212384 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 2 Non-Comparative Study Of The Efficacy Of PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Clinical Benefit Response (CBR) [ Time Frame: 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With Objective Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: 12.0 ] [ Designated as safety issue: No ]
- Progression-Free Survival (PFS) [ Time Frame: 12 ] [ Designated as safety issue: No ]
- Progression-Free Survival (PFS) [ Time Frame: 6 ] [ Designated as safety issue: No ]
- Area under the Concentration-Time Curve (AUC) [ Time Frame: Pre-dose, and post dose at 0.5, 1, 2, 3, 4, 6, and 24 hours post dose. Pre dose cycles 2, 3, 4 ] [ Designated as safety issue: No ]
- Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 24, 72, and 120 hours post dose and pre and 0.5 hour post dose cycles 2, 3, 4 ] [ Designated as safety issue: No ]
- Expression and/or phosphorylation in biopsied tumor tissue of PI3K pathway proteins [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
- Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B
PI3K Basal, IV Compound
|
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
|
|
Experimental: C
PI3K Activated, Oral Compound
|
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
|
|
Experimental: F
Japanese lead in cohort, IV compound
|
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Recurrent endometrial carcinoma
- Disease progression following one or two lines of prior treatment with platinum containing chemotherapy
- Tumor tissue available at time of screening for PI3K analysis
- Adequate performance status
- Adequate glucose control, bone marrow, kidney, liver, and heart function
Exclusion Criteria:
- More than 2 prior cytotoxic chemo regimens for endometrial carcinoma
- Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor
- Active brain metastases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420081
Hide Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, Alabama | |
| Pfizer Investigational Site | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Pfizer Investigational Site | Recruiting |
| Birmingham, Alabama, United States, 35249-7333 | |
| Pfizer Investigational Site | Recruiting |
| Birmingham, Alabama, United States, 35249 | |
| Pfizer Investigational Site | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| La Jolla, California, United States, 92093 | |
| Pfizer Investigational Site | Recruiting |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | Recruiting |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Coral Gables, Florida, United States, 33133 | |
| Pfizer Investigational Site | Recruiting |
| Miami, Florida, United States, 33133 | |
| United States, Georgia | |
| Pfizer Investigational Site | Not yet recruiting |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| Pfizer Investigational Site | Not yet recruiting |
| Fairway, Kansas, United States, 66205 | |
| Pfizer Investigational Site | Not yet recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Pfizer Investigational Site | Not yet recruiting |
| Westwood, Kansas, United States, 66205 | |
| United States, Louisiana | |
| Pfizer Investigational Site | Recruiting |
| Covington, Louisiana, United States, 70433 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Pfizer Investigational Site | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New Mexico | |
| Pfizer Investigational Site | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Australia, Victoria | |
| Pfizer Investigational Site | Recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Canada, Alberta | |
| Pfizer Investigational Site | Not yet recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Pfizer Investigational Site | Not yet recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| Pfizer Investigational Site | Recruiting |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Pfizer Investigational Site | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Pfizer Investigational Site | Not yet recruiting |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Pfizer Investigational Site | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Japan | |
| Pfizer Investigational Site | Active, not recruiting |
| Nagoya, Aichi, Japan | |
| Pfizer Investigational Site | Active, not recruiting |
| Akashi, Hyogo, Japan | |
| Pfizer Investigational Site | Active, not recruiting |
| Hidaka, Saitama, Japan | |
| Pfizer Investigational Site | Active, not recruiting |
| Chuo-Ku, Tokyo, Japan | |
| Poland | |
| Pfizer Investigational Site | Not yet recruiting |
| Lodz, Poland, 93-509 | |
| Pfizer Investigational Site | Recruiting |
| Lublin, Poland, 20-090 | |
| Pfizer Investigational Site | Not yet recruiting |
| Poznan, Poland, 61- 866 | |
| Pfizer Investigational Site | Not yet recruiting |
| Poznan, Poland, 61-878 | |
| Russian Federation | |
| Pfizer Investigational Site | Recruiting |
| Krasnodar, Russian Federation, 350040 | |
| Pfizer Investigational Site | Recruiting |
| Pyatigorsk, Russian Federation, 35702 | |
| Pfizer Investigational Site | Not yet recruiting |
| Ryazan, Russian Federation, 390011 | |
| Pfizer Investigational Site | Recruiting |
| Saint Petersburg, Russian Federation, 198255 | |
| Pfizer Investigational Site | Not yet recruiting |
| Ufa, Russian Federation, 450054 | |
| Slovakia | |
| Pfizer Investigational Site | Not yet recruiting |
| Bratislava, Slovakia, 833 10 | |
| Pfizer Investigational Site | Not yet recruiting |
| Presov, Slovakia, 08001 | |
| Spain | |
| Pfizer Investigational Site | Recruiting |
| Barcelona, Spain, 08035 | |
| Pfizer Investigational Site | Not yet recruiting |
| Madrid, Spain, 28046 | |
| Pfizer Investigational Site | Recruiting |
| Madrid, Spain, 28033 | |
| Pfizer Investigational Site | Recruiting |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | Recruiting |
| Valencia, Spain, 46009 | |
| United Kingdom | |
| Pfizer Investigational Site | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Pfizer Investigational Site | Not yet recruiting |
| Glasgow, Scotland, United Kingdom | |
| Pfizer Investigational Site | Not yet recruiting |
| Bebington, Wirral, United Kingdom, CH63 4JY | |
| Pfizer Investigational Site | Not yet recruiting |
| London, United Kingdom, NW1 2PG | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01420081 History of Changes |
| Other Study ID Numbers: | B1271004 |
| Study First Received: | August 17, 2011 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
uterine neoplasms endometrial uterine cancer PI3K |
mTOR PI3K/mTOR recurrent metastatic |
Additional relevant MeSH terms:
|
Neoplasms Endometrial Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Diseases Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013