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
223
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