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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
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: OMP-54F28, Paclitaxel and Carboplatin Phase 1

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug: OMP-54F28, Paclitaxel and Carboplatin Drug: OMP-54F28, Paclitaxel and Carboplatin
Other Names:
  • OMP-54F28
  • Paclitaxel
  • Carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
More Information
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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
Keywords provided by Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. ):
Platinum-Sensitive Ovarian Cancer
Additional relevant MeSH terms:
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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