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

Brief Title

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

Official Title

A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Fallopian Tube Cancer

Intervention

AMG386 plus PLD

Study Arms / Comparison Groups

 Placebo plus PLD

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 18, 2011

Completion Date

April 19, 2017

Primary Completion Date

August 29, 2014

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

MD, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT01281254

Organization ID

20060517

Secondary IDs

2009-017946-30

Responsible Party

Sponsor

Study Sponsor

Amgen

Study Sponsor

MD, Study Director, Amgen

Verification Date

November 2017