AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

Phase 3

Terminated

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer
• Interventions: Drug: Placebo plus PLD; Drug: AMG386 plus PLD

• Registration Number: NCT01281254
• Lead Sponsor: Amgen

Brief Summary

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-04-18
• Primary Completion: 2014-08-29
• Disposition First Submitted: 2015-04-23
• Disposition First Submitted QC: 2015-04-23
• Disposition First Posted: 2015-05-12
• Study Completion: 2017-04-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 223

Inclusion Criteria

• Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
• Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
• Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
• Female 18 years of age or older at the time the written informed consent is obtained
• Adequate organ and hematological function

Exclusion Criteria

• Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
• Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
• Subjects with primary platinum-refractory disease
• Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
• History of central nervous system metastasis
• Major surgery within 28 days prior to randomization or still recovering from prior surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus PLD	Placebo plus PLD	Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
AMG386 plus PLD	AMG386 plus PLD	Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)

Primary Outcome Measures

Name	Time	Method
To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications	Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.

Secondary Outcome Measures

Name	Time	Method
• To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival	weekly

Trial Locations

Locations (1)

Research Site; 🇬🇧 Poole, United Kingdom