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

NCT03030287CompletedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

OncoMed Pharmaceuticals, Inc.

Enrollment

44

Start Date

2016-12-01

Completion Date

2020-04-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

OMP-305B83Paclitaxel

Conditions

Cancer OvariesCancer PeritonealCancerFallopian Tube

Eligibility

Age Range

21 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Incidence of dose limiting toxicities (DLT)

The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel

Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).

Secondary Outcomes

Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.

Time frame: Through study completion, an average of 6 months

To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel

Time frame: Through study completion, an average of 6 months

Response Rate assessed by RECIST criteria 1.1

Time frame: At 56 day intervals while on treatment, through study completion, an average of 6 months

Response Rate assessed by CA-125 criteria

Time frame: At 28 day intervals while on treatment, through study completion, an average of 6 months

Progression Free Survival

Time frame: Up to 5 years

Locations

University of Colorado, Anschutz Medical Campus, Aurora, United States

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

Levine Cancer Institute, Charlotte, United States

Stephenson Cancer Center, Oklahoma City, United States

The University of Pennsylvania Health System, Philadelphia, United States

Tennessee Oncology, PLLC, Nashville, United States

The University of Texas, MD Anderson Cancer Center, Houston, United States

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