Ovarian Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to
estimate the improvement in PFS (compared to control subjects) and evaluate the safety and
tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with
advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome Measure:
• Progression free survival (PFS)
Secondary Outcome Measures:
- Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
- Safety and Tolerability
- Change and duration of change on blood levels of CA-125
Primary Objective:
To estimate the treatment effect as measured by progression free survival (PFS) of subjects
with recurrent ovarian cancer receiving AMG 386 (either 3 mg/kg or 10 mg/kg IV QW) in
combination with paclitaxel (80 mg/m2 IV QW; 3 on/1 off)compared to subjects receiving
paclitaxel (80 mg/m2 IV QW; 3 on/1 off) plus placebo
Secondary Objective(s):
- To evaluate the safety and tolerability of the combination regimen of AMG 386/paclitaxel
- To estimate other measures of treatment effect (by parameters other than PFS) of
subjects receiving AMG 386 in combination with paclitaxel compared to subjects receiving
paclitaxel plus placebo
- To evaluate the AMG 386 pharmacokinetics parameters (Cmax and Cmin ) when administered
with paclitaxel in subjects with recurrent ovarian cancer
- To estimate the incidence of occurrence of anti-AMG 386 antibody formation
- To estimate the change and duration of change on blood levels of CA-125
- To evaluate the clinical benefit among subjects receiving AMG 386 10 mg/kg monotherapy
after disease progression on paclitaxel
- To estimate the impact of AMG 386 on patient reported ovarian cancer specific symptoms
and HRQoL using the FACT-O, the FACT-O ovarian cancer subscale (OCS), and the FACT-O
3-item (O1, O2, O3) cancer symptom specific subscale (OCS 3-item subscale)
Exploratory Objective(s):
- To explore the associations between progression free survival, objective response,
CA-125, and continuous measures of tumor burden (the percentage change from baseline in
the sum of the longest diameters of target lesions)
- To explore the pharmacodynamic (PD) response as assessed by changes in blood levels of
angiogenic cytokines, tumor apoptosis, CA-125 and other markers
- To investigate the effects of genetic variation in drug metabolism, cancer genes and
drug target genes on ovarian cancer and subject response to investigational product
(separate informed consent)
- To explore the impact of AMG 386 on patient reported overall health status as measured
by the EuroQoL (EQ-5D)
Hypothesis:
This study will provide an estimate and corresponding 2-sided 80% confidence interval with an
approximate maximum half-width of 0.22 of the efficacy, as measured by the PFS hazard ratio
of AMG 386 in combination with paclitaxel versus paclitaxel alone for 2 pooled dose groups of
AMG 386 (10 mg/kg QW and 3 mg/kg QW) in combination with paclitaxel versus the paclitaxel
plus placebo group.
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