Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer

NCT02092363 | Completed Phase 1

• 1 other identifier: 54F28-003
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL • min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and carboplatin will be given. Additional cycles may be given as per institutional standard of care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg.

Conditions

Ovarian Cancer

Keywords

Platinum-Sensitive Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of OMP-54F28 in combination with paclitaxel and carboplatin in patients with recurrent platinum-sensitive ovarian cancer

  The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28/paclitaxel/carboplatin (from Day 0 - 21)

  Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 21)

Study Arms (1)

Drug: OMP-54F28, Paclitaxel and Carboplatin

EXPERIMENTAL

Drug: OMP-54F28, Paclitaxel and Carboplatin

Interventions

OMP-54F28, Paclitaxel and Carboplatin DRUG

Also known as: OMP-54F28, Paclitaxel, Carboplatin

Drug: OMP-54F28, Paclitaxel and Carboplatin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Age ≥18 years
• Histologically documented ovarian, primary peritoneal or fallopian tube cancer
• Recurrent platinum-sensitive disease, defined as disease progression ≥6 months after completing a minimum of 4 cycles of a platinum-containing regimen
• Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy
• o Tumor tissue from fine needle aspiration is not acceptable.
• ECOG performance status of 0 or 1
• All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
• Adequate hematologic and end-organ function
• Evaluable or measurable disease per RECIST v1.1
• For women of childbearing potential, agreement to use two effective forms of contraception

You may not qualify if:

• Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors
• Prior treatment with paclitaxel and carboplatin for recurrent platinum-sensitive ovarian cancer
• Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter
• Known hypersensitivity to any component of study treatments that resulted in drug discontinuation
• Grade ≥ 2 sensory neuropathy
• Uncontrolled seizure disorder or active neurologic disease
• Untreated brain metastases
• Leptomeningeal disease as a manifestation of cancer
• Active infection requiring antibiotics
• Bisphosphonate therapy for symptomatic hypercalcemia
• Known history of clinically significant liver disease, including active viral hepatitis and cirrhosis
• Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Pregnancy, lactation, or breastfeeding
• Known HIV infection
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (4)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

OU Medical Center Laboratory

Oklahoma City, Oklahoma, 73104-5047, United States

Location

The University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Fox-Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

OMP-54F28; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: March 20, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

US (4)