Clinical Trials/NCT01204749

NCT01204749

Completed

Phase 3

A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

Amgen1 site in 1 country919 target enrollmentNovember 2010

ConditionsFallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cancer

InterventionsAMG 386 Paclitaxel AMG 386 Placebo

DrugsAMG 386 AMG 386 Placebo Paclitaxel

Overview

Phase: Phase 3
Intervention: AMG 386
Conditions: Fallopian Tube Cancer
Sponsor: Amgen
Enrollment: 919
Locations: 1
Primary Endpoint: Progression-Free Survival
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

December 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female 18 years of age or older at the time the written informed consent is obtained
•Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
•Life expectancy \>= 3 months (per investigator opinion)
•Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
•Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
•Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications
•Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
•Adequate organ and hematological function
•Generally well controlled blood pressure with systolic blood pressure \<= 140 mmHg and diastolic blood pressure \<= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted
•Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

Exclusion Criteria

•Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
•Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
•Subjects with primary platinum-refractory disease
•Subjects with platinum-free interval (PFI) \> 12 months from their last platinum based therapy
•Radiotherapy \<= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
•Previous abdominal or pelvic radiotherapy
•History of arterial or venous thromboembolism within 12 months prior to randomization
•History of clinically significant bleeding within 6 months prior to randomization
•History of central nervous system metastasis
•Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab)

Arms & Interventions

AMG 386

Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW

Intervention: AMG 386

AMG 386

Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW

Intervention: Paclitaxel

AMG 386 Placebo

Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW

Intervention: AMG 386 Placebo

AMG 386 Placebo

Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW

Intervention: Paclitaxel

Outcomes

Primary Outcomes

Progression-Free Survival

Time Frame: 8 Months on average

Secondary Outcomes

Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O)(From week 1 until 30-days following last study drug administration)
Overall survival(20 months on average)
Duration of response(From Baseline until progression)
CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125(From Baseline until CA-125 response)
Incidence of adverse events and significant laboratory abnormalities(8 Months on average)
Pharmacokinetics of AMG 386 (Cmax and Cmin)(Week 1 until week 9 of treatment)
Objective Response Rate(From Baseline (if subject has Measurable Disease) until objective response (radiologic))
Overall health status using EuroQOL(EQ-5D)(From week 1 until 30-days following last study drug administration)
Incidence of the occurrence of anti-AMG 386 antibody formation(Week 1 until maximum of 1-year following last dose of study drug)