Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02092363 |
Recruitment Status :
Completed
First Posted : March 20, 2014
Last Update Posted : August 12, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Drug: OMP-54F28, Paclitaxel and Carboplatin | Phase 1 |
Depending on safety in this study, additional lower or intermediate dose levels may be evaluated. Depending on emerging safety data from the Phase 1a study 54F28-001 with continuing dose escalation, additional higher dose levels of OMP-54F28 may be evaluated in this study. Alternative dosing schedules of OMP-54F28 may be explored based on emerging nonclinical and clinical data for safety, PD, PK and efficacy. The starting dose for a new dosing schedule will be chosen to result in an AUC equivalent to the highest dose level that cleared on the previously studied dosing schedule. No dose escalation of OMP-54F28 will be allowed within a dose cohort.
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of OMP-54F28 combined with paclitaxel and carboplatin. Up to approximately 34 patients may be enrolled into the study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Drug: OMP-54F28, Paclitaxel and Carboplatin |
Drug: OMP-54F28, Paclitaxel and Carboplatin
Other Names:
|
- Safety and tolerability of OMP-54F28 in combination with paclitaxel and carboplatin in patients with recurrent platinum-sensitive ovarian cancer [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 21) ]The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28/paclitaxel/carboplatin (from Day 0 - 21)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Concurrent use of therapeutic warfarin
- New York Heart Association Classification III or IV
- Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
- Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
-
Bone metastases and one of the following:
- Prior history of a pathologic fracture
- Lytic lesion requiring an impending orthopedic intervention
- Lack of treatment with a bisphosphonate or denosumab
- Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone) and Avandia® (rosiglitzone)
- Active treatment with an oral or IV glucocortocoid for ≥4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
- Fasting β-CTX of >1000 pg/mL
- Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092363
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Oklahoma | |
OU Medical Center Laboratory | |
Oklahoma City, Oklahoma, United States, 73104-5047 | |
United States, Pennsylvania | |
The University of Pennsylvania Health System | |
Philadelphia, Pennsylvania, United States, 19104 | |
Fox-Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Responsible Party: | OncoMed Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02092363 |
Other Study ID Numbers: |
54F28-003 |
First Posted: | March 20, 2014 Key Record Dates |
Last Update Posted: | August 12, 2020 |
Last Verified: | August 2020 |
Platinum-Sensitive Ovarian Cancer |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Hypersensitivity Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immune System Diseases Paclitaxel Albumin-Bound Paclitaxel Carboplatin Immunoglobulin Fc Fragments Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |