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

Amgen

Status and phase: Terminated; Phase 3

Conditions: Primary Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: AMG386 plus PLD; Drug: Placebo plus PLD

Study type: Interventional

Funder types: Industry

Identifiers

NCT01281254

ENGOT-ov-6

2009-017946-30 (EudraCT Number)

20060517 (Other Identifier)

TRINOVA-2 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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223 participants in 2 patient groups, including a placebo group

Placebo plus PLD

Placebo Comparator group

Description:

Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)

Treatment:

Drug: Placebo plus PLD

AMG386 plus PLD

Experimental group

Description:

Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)

Treatment:

Drug: AMG386 plus PLD