Phase 2
Completed N=153
Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")
Ovarian Cancer · Fallopian Tube Neoplasms · Peritoneal Neoplasm
Source: ClinicalTrials.gov NCT00391118 ↗
Enrolled (actual)
153
Serious AEs
35.3%
Results posted
Oct 2020
Primary outcomePrimary: Part 2: Progression-Free Survival (PFS) — 18.9; 15.2 months
Summary
Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many participants the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many participants. This trial will try to address the question: Can we delay the time till the tumor grows again by adding a 3rd drug to the standard therapy? To answer this question, participants will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy. Participants and physicians will not know if a participant gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of participants with tumor growth at a specific time point will be compared between the two treatments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 2: Progression-Free Survival (PFS) |
18.9; 15.2 | — |
| SECONDARY Part 2: Percentage of Participants With PFS at 2 Years |
35.2; 28.2 | — |
| SECONDARY Part 2: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] |
42.9; 38.9 | — |
| SECONDARY Part 2: Percentage of Participants With CR or PR or Stable Disease (SD) (Rate of Response) |
7.1; 22.2; 35.7; 16.7; 42.9; 50.0 | — |
| SECONDARY Part 2: Translational Research: PFS Based on Protein Expression (PE) (To Assess Biological Markers in Tumors That Could Indicate Who Could Benefit From Enzastaurin Treatment) |
18.9; 10.4; 19.1; 18.2; 18.9; 18.2 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs) and the Number of Participants Who Died (To Compare the Safety of the 2 Treatments) |
7; 26; 20; 11; 60; 56 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) for Carboplatin With and Without Enzastaurin for Part 1 of Study |
11.1; 10.8 | — |
| SECONDARY PK: Cmax for Paclitaxel With and Without Enzastaurin for Part 1 of Study |
3580; 3670 | — |
| SECONDARY PK: AUC From Time 0 to Infinity (AUC0-∞) for Carboplatin With and Without Enzastaurin for Part 1 of Study |
3.32; 3.80 | — |
| SECONDARY PK: AUC0-∞ for Paclitaxel With and Without Enzastaurin for Part 1 of Study |
12000; 14400 | — |
| SECONDARY PK: Cmax at Steady State (Cmax,ss) for Part 1 of Study |
1230; 935; 890; 814; 2190; 1640 | — |
| SECONDARY PK: AUC During the Dosing Interval at Steady State (AUCτ,ss) for Part 2 of Study |
47100; 55600; 106000 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have specific stages of disease, known as Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stages IIB, IIC, III or IV
- Organ functions (blood, renal, liver, cardiac) must meet specific requirements.
- Participants who could become pregnant must take care not to become pregnant during the study participation and for 6 months after study discontinuation
- Participants must give written consent for study participation.
Exclusion Criteria
- Participants received any experimental drug within the last 30 days.
- Participants received any prior chemotherapy or other drug therapy for the current disease.
- Participants receive any other treatment for the cancer during study participation.
- Participants are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
- Participants are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.
Data sourced from ClinicalTrials.gov (NCT00391118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.