A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer

NCT ID: NCT03030287

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-04-30

Brief Summary

The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

Detailed Description

This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..

Conditions

Cancer Ovaries; Cancer Peritoneal; Cancer, Fallopian Tube

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OMP-305B83 plus paclitaxel

Group Type: EXPERIMENTAL

OMP-305B83

Intervention Type: DRUG

intravenous (in the vein) infusion

Paclitaxel

Intervention Type: DRUG

administered intravenously

Interventions

OMP-305B83

intravenous (in the vein) infusion

Intervention Type: DRUG

Paclitaxel

administered intravenously

Intervention Type: DRUG

Other Intervention Names

bispecific monoclonal antibody

Eligibility Criteria

Inclusion Criteria

1. Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer

2. Measureable disease per response evaluation criteria (RECIST) v1.1

3. Prior bevacizumab

4. Age > or = 21 years

5. Adequate organ and marrow function

6. For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.

7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

1. Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.

2. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.

3. Subjects with brain metastases

4. Subjects with leptomeningial disease or neoplasms in the last 5 years

5. Blood pressure >140/80

6. Significant intercurrent illness that will limit the patient's ability to participate in the study

7. Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.

8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study

9. Pregnant or nursing women

10. New York Heart Association Classification II, III, or IV

11. Inability to comply with study and follow up procedure

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

OncoMed Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center)

Tampa, Florida, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

The University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Fu S, Corr BR, Culm-Merdek K, Mockbee C, Youssoufian H, Stagg R, Naumann RW, Wenham RM, Rosengarten RD, Benjamin L, Hamilton EP, Moore KN. Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. J Clin Oncol. 2022 Aug 10;40(23):2568-2577. doi: 10.1200/JCO.21.01801. Epub 2022 Apr 19.

Reference Type: DERIVED

PMID: 35439029 (View on PubMed)

Other Identifiers

B83-002

Identifier Type: -

Identifier Source: org_study_id