Clinical trial · Interventional
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
NCT01420081CI-TRIAL-00036393terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-05212384 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- B
- description
- PI3K Basal, IV Compound
- interventionNames
- Drug: PF-05212384
- type
- EXPERIMENTAL
- label
- C
- description
- PI3K Activated, Oral Compound
- interventionNames
- Drug: PF-05212384
- type
- EXPERIMENTAL
- label
- F
- description
- Japanese lead in cohort, IV compound
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDel Campo JM, Birrer M, Davis C, Fujiwara K, Gollerkeri A, Gore M, Houk B, Lau S, Poveda A, Gonzalez-Martin A, Muller C, Muro K, Pierce K, Suzuki M, Vermette J, Oza A. A randomized phase II non-comparative study of PF-04691502 and gedatolisib (PF-05212384) in patients with recurrent endometrial cancer. Gynecol Oncol. 2016 Jul;142(1):62-69. doi: 10.1016/j.ygyno.2016.04.019. Epub 2016 Apr 24. PMID 27103175