A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Active, not recruiting

• Conditions: Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers; MedDRA version: 18.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019821-32-SE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-11
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 919

Inclusion Criteria

Disease Related
• Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology are excluded
- Subjects with borderline ovarian cancer, ie, subjects with low malignant potential tumors, are excluded
- Subjects with clear cell or mucinous histology are excluded
• Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
• Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
• Radiologically evaluable disease per RECIST 1.1 with modifications
- There must be radiographically visible tumor
- Subjects with only ascites or pleural effusion are excluded
• Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
- Subjects are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease.

Demographic
• Female 18 years of age or older at the time the written informed consent is obtained
• 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 non-hormonal method of contraception [ie, double barrier method (eg, condom plus diaphragm)] from signing the informed consent through 6 months after last dose of study drug

General
• Generally well-controlled blood pressure with systolic blood pressure
= 140 mmHg AND diastolic blood pressure = 90 mmHg prior to randomization.
The use of anti-hypertensive medications to control hypertension is permitted.
GOG Performance Status of 0 or 1 (see Appendix H)
• Life expectancy = 3 months (per investigator opinion)
• Subject plans to begin protocol-directed therapy within 7 days from randomization

Laboratory
• Adequate organ and hematological function as evidenced by the following laboratory
studies prior to randomization:
- Hematological function (see protocol for definition)
- Renal function (see protocol for definition)
- PTT or aPTT = 1.5 x ULN per institutional laboratory range and INR = 1.5
- Hepatic function (see protocol for definition)
- Nutritional (see protocol for definition)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 651
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 268

Exclusion Criteria

Disease Related
• Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
• Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
• Subjects with primary platinum-refractory disease
- Subjects with recurrence or progression during the first 6 cycles or < 6 months after the beginning of the first-line platinum-based chemotherapy are excluded
• Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy
• Radiotherapy = 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
- If all sites of disease have been irradiated, documented progression must have occurred in at least 1 site of disease subsequent to the radiation therapy
• Previous abdominal or pelvic radiotherapy
• History of arterial or venous thromboembolism within 12 months prior to randomization
• History of clinically significant bleeding within 6 months prior to randomization
• History of central nervous system metastasis
Medications
• Has not yet completed a 21 day washout period prior to randomization for any previous anti-cancer systemic therapies (30 days for prior bevacizumab)
• Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments
• Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 = Grade 2 in severity except alopecia
• Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
• Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
• Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
General Medical
• Clinically significant cardiovascular disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent
• Subjects with a history of prior malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for = 3 years prior to randomization 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
• Major surgery within 28 days prior to randomization or still recovering from prior surgery
• Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.
• History of allergic reactions to bacterially-produced proteins
• Hypersensitivity to paclitaxel or drugs using the vehicle cremo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified