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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: AMG 386
* Drug: Paclitaxel
* Drug: AMG 386 Placebo
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Paclitaxel Carboplatin | Drug: Paclitaxel<br>* Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)<br>Drug: AMG 386 Placebo<br>* AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)<br>Drug: Carboplatin<br>* Carboplatin AUC 5 or 6 IV Q3W (6 cycles)<br>|
| Active Comparator: AMG 386<br>AMG 386 Paclitaxel Carboplatin | Drug: AMG 386<br>* AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)<br>Drug: Paclitaxel<br>* Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)<br>Drug: Carboplatin<br>* Carboplatin AUC 5 or 6 IV Q3W (6 cycles)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 5 years | 
| Incidence of adverse events and significant laboratory abnormalities |  | 4 years | 
| Pharmacokinetics of AMG 386 (Cmax and Cmin) | pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7 | 1 year | 
| Incidence of anti-AMG 386 antibody formation | pre-dose weeks 1, 10, 19 | 4 years | 
| Patient reported ovarian cancer-specific symptoms and health related quality of life |  | 4 years | 
| Patient reported status as measured by the EuroQOL (EQ-5D) |  | 4 years | 
| AMG 386 exposure-response relationships for PFS and OS |  | 4 years | 
| Correlation of serum biomarkers with measures of response |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Peritoneal Cancer