Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479817
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2007-05-24
Brief Title:
Phase 2 AMG 386 in Comb Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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
Detailed Description:
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 mgkg or 10 mgkg IV QW in combination with paclitaxel 80 mgm2 IV QW 3 on1 offcompared to subjects receiving paclitaxel 80 mgm2 IV QW 3 on1 off plus placebo
Secondary Objectives
To evaluate the safety and tolerability of the combination regimen of AMG 386paclitaxel
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 mgkg 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 Objectives
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 022 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 mgkg QW and 3 mgkg QW in combination with paclitaxel versus the paclitaxel plus placebo group
To estimate the treatment effect as measured by progression free survival PFS of subjects with recurrent ovarian cancer receiving AMG 386 either 3 mgkg or 10 mgkg IV QW in combination with paclitaxel 80 mgm2 IV QW 3 on1 offcompared to subjects receiving paclitaxel 80 mgm2 IV QW 3 on1 off plus placebo
Secondary Objectives
To evaluate the safety and tolerability of the combination regimen of AMG 386paclitaxel
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 mgkg 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 Objectives
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 022 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 mgkg QW and 3 mgkg QW in combination with paclitaxel versus the paclitaxel plus placebo group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None