TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

Amgen

Status and phase: Terminated; Phase 3

Conditions: Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: AMG 386; Drug: Carboplatin; Drug: Paclitaxel; Drug: AMG 386 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01493505

TRINOVA-3 20101129/ENGOT-ov2

20101129

Details and patient eligibility

About

The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.

Enrollment: 1,015 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
• Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
• Subjects with FIGO Stage IIIC or IV disease must either:
• Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
• Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
• ECOG performance status of 0 or 1
• Adequate bone marrow, renal and hepatic function

Exclusion criteria

• Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
• Previous abdominal and/or pelvic external beam radiotherapy
• History of central nervous metastasis
• History of arterial or venous thromboembolism within 12 months prior to randomization
• Clinically significant cardiovascular disease within 12 months prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,015 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Paclitaxel Carboplatin

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: AMG 386 Placebo

AMG 386

Active Comparator group

Description:

AMG 386 Paclitaxel Carboplatin

Treatment:

Drug: Paclitaxel

Drug: AMG 386

Drug: Carboplatin