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Phase 2 AMG 386 in Comb. Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer

NCT00479817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-12-18

No results posted yet for this study

Summary

This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Primary Outcome Measure:

• Progression free survival (PFS)

Secondary Outcome Measures:

* Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
* Safety and Tolerability
* Change and duration of change on blood levels of CA-125

Conditions

Interventions

DRUG

AMG 386

10mg/kg

DRUG

AMG 386

3 mg/kg

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 IV QW (3 on/1 off)

DRUG

AMG 386 Placebo

AMG 386 Placebo

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-05
Primary Completion
2009-08-11
Completion
2019-12-09

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479817 on ClinicalTrials.gov