A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

Phase 1

Active, not recruiting

• Conditions: Recurrent partially platinum sensitive or resistant epithelial ovarian, primaryperitoneal or fallopian tube cancers; MedDRA version: 12.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-07
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 900

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
• 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
• Current or treatment within 30 days prior to randomization with immune modulators such as systemic cyclosporine or tacrolimus
General Medical
• Clinically significant cardiac 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
• Uncontrolled hypertension as defined as diastolic blood pressure > 90 mmHg OR
systolic blood pressure > 140 mmHg. The use of anti-hypertensive medications to
control hypertension is permitted.
• 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, including placement of tunneled central venous access
device within 3 days prior to randomization
• History of allergic reactions to bacterially-produced proteins
• Hypersensitivity to paclitaxel or drugs using the vehicle cremophor
• Pregnant (ie, pos

Study & Design

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