AMG 386 1st Ovarian cancer Global Phase 3 clinical trial

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221781

Enrollment

2000

Registered

2012-04-26

Start date

2012-04-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line treatment of subjects with International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers

Interventions

investigational material(s) Generic name etc : AMG 386 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
PFS Intergroup trial	—

Secondary

Measure	Time frame
OS Intergroup trial	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026