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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
N/A
Open (Enrolling)
Female
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
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:

- 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
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

Type of Study:

Interventional

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:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20070182

NCT ID:

NCT00770536

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

Name

Location

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