Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
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
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically documented recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer
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
You may not be if
Subjects believed to be a higher than average risk of bowel perforation. This includes symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, subjects requiring total parenteral nutrition and continuous hydration
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
