Overview

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

Status:
Terminated
Trial end date:
2017-04-19
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Doxorubicin
Liposomal doxorubicin
Trebananib
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