Trials / Completed
CompletedNCT00770536
AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR
A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion. It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.
Detailed description
The purpose of this study is to evaluate the effectiveness and safety of AMG 386 when used with pegylated liposomal doxorubicin or topotecan in subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Conditions
- Cancer
- Carcinoma
- Fallopian Tube Cancer
- Gynecological Malignancies
- Metastases
- Oncology
- Ovarian Cancer
- Solid Tumors
- Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | A1: AMG 386 10 mg/kg + Liposomal doxorubicin | Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW |
| DRUG | A3: AMG 386 15mg/kg + Liposomal doxorubicin | A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W |
| DRUG | B1: AMG 386 10 mg/kg + Topotecan | B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule |
| DRUG | B3: AMG 386 15mg/kg + Topotecan | AMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2012-01-01
- Completion
- 2015-06-01
- First posted
- 2008-10-10
- Last updated
- 2015-09-29
Locations
16 sites across 3 countries: United States, Australia, Belgium
Source: ClinicalTrials.gov record NCT00770536. Inclusion in this directory is not an endorsement.