AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR
NCT ID: NCT00770536
Last Updated: 2015-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2009-01-31
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1
In part 1, six subjects will be assigned to each cohort A or B. This is a dose escalation/de escalation study with a 6 + 3 design based on the incidence of DLTs (dose limiting toxicities) during the first 4 weeks of combined therapy \[(cohort A: AMG 386 and pegylated liposomal doxorubicin) or (cohort B: AMG 386 and topotecan)\].
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
A3: AMG 386 15mg/kg + Liposomal doxorubicin
A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W
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
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
Part 2
The decision on declaration of a safe and tolerable dose during part 1 will lead to part 2 (cohort A: liposomal doxorubicin + AMG 386 MTD (max tolerated dose) of part 1, cohort B: Topotecan + AMG 386 MTD (max tolerated dose) of part 1
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
A3: AMG 386 15mg/kg + Liposomal doxorubicin
A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W
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
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
Interventions
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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
A3: AMG 386 15mg/kg + Liposomal doxorubicin
A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have received at least one platinum containing regimen
* Radiographically documented progression per RECIST criteria with modifications or progression of CA 125 as adopted by GCIG during or subsequent to the last chemotherapy regimen
* Subjects may include those with measurable or non measurable disease
* All scans and x-rays used to document measurable or non measurable disease must be done within 28 days prior to enrollment
* Female 18 years of age or older at the time the written informed consent is obtained
* GOG Performance Status of 0 or 1
* Left Ventricular Ejection Fraction (LVEF) \>= institutional lower limit of normal for subjects assigned to cohort A only
* Adequate organ function as assessed by laboratory studies (hematological and chemistries)
* Life expectancy \>= 3 months (per investigator opinion)
* Subjects of child bearing potential who have not undergone a bilateral salpingo oophorectomy and are sexually active must consent to use an accepted and effective double barrier non hormonal method of contraception from signing the informed consent through 6 months after last dose of study drug
Exclusion Criteria
* Previous abdominal /or pelvic external beam radiotherapy
* Known history of central nervous system metastases
* Subjects with a history of prior malignancy, except:
* Malignancy treated with curative intent and with no known active disease present for \>= 3 years before study day 1 and felt to be at low risk for recurrence by treating physician
* Adequately treated non melanomatous skin cancer or lentigo maligna without evidence of disease
* Adequately treated cervical carcinoma in situ without evidence of disease
* Prior myeloablative high dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant
* History of arterial or deep venous thromboembolism within 12 months prior to enrollment
* Clinically significant cardiac disease within 12 months prior to enrollment
* Prior treatment with doxorubicin or pegylated liposomal doxorubicin (cohort A subjects) and topotecan (cohort B subjects)
* Current or within 30 days prior to enrollment treatment with immune modulators such as systemic cyclosporine and tacrolimus
18 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Tucson, Arizona, United States
Research Site
Sacramento, California, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Saint Louis Park, Minnesota, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Columbus, Ohio, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Adelaide, South Australia, Australia
Research Site
Footscray, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Liège, , Belgium
Research Site
Wilrijk, , Belgium
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20070182
Identifier Type: -
Identifier Source: org_study_id
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