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A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer

Phase 1
18 Years
Open (Enrolling)
Cancer, Carcinoma, Fallopian Tube Cancer, Gynecological Malignancies, Metastases, Oncology, Ovarian Cancer, Solid Tumors, Tumors

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Trial Information

A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer

Inclusion Criteria:

- 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

- 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:

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan

Outcome Time Frame:

first 4 weeks of treatment

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

October 2013

Related Keywords:

  • Cancer
  • Carcinoma
  • Fallopian Tube Cancer
  • Gynecological Malignancies
  • Metastases
  • Oncology
  • Ovarian Cancer
  • Solid Tumors
  • Tumors
  • fallopian tube cancer
  • Gynecological Malignancy
  • primary peritoneal cancer of predominantly epithelial origin
  • Stage II to IV ovarian cancer
  • Neoplasms
  • Carcinoma
  • Neoplasm Metastasis
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteAlexandria, Minnesota  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania