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

Primary Purpose

Cancer Ovaries, Cancer Peritoneal, Cancer, Fallopian Tube

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OMP-305B83

Paclitaxel

About this trial

This is an interventional treatment trial for Cancer Ovaries

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
Measureable disease per response evaluation criteria (RECIST) v1.1
Prior bevacizumab
Age > or = 21 years
Adequate organ and marrow function
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.
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

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.
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
Subjects with brain metastases
Subjects with leptomeningial disease or neoplasms in the last 5 years
Blood pressure >140/80
Significant intercurrent illness that will limit the patient's ability to participate in the study
Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
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
Pregnant or nursing women
New York Heart Association Classification II, III, or IV
Inability to comply with study and follow up procedure

Sites / Locations

University of Colorado, Anschutz Medical Campus
H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center)
Levine Cancer Institute
Stephenson Cancer Center
The University of Pennsylvania Health System
Tennessee Oncology, PLLC
The University of Texas, MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMP-305B83 plus paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Response Rate assessed by RECIST criteria 1.1

Response Rate assessed by CA-125 criteria

Progression Free Survival

Full Information

NCT ID

NCT03030287

First Posted

January 13, 2017

Last Updated

September 2, 2020

Sponsor

OncoMed Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03030287

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

April 2020 (Actual)

Study Completion Date

April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OncoMed Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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)..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Ovaries, Cancer Peritoneal, Cancer, Fallopian Tube

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMP-305B83 plus paclitaxel

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

OMP-305B83

Other Intervention Name(s)

bispecific monoclonal antibody

Intervention Description

intravenous (in the vein) infusion

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

administered intravenously

Primary Outcome Measure Information:

Title

Incidence of dose limiting toxicities (DLT)

Description

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 Outcome Measure Information:

Title

Time Frame

Through study completion, an average of 6 months

Title

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

Title

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

Title

Response Rate assessed by CA-125 criteria

Time Frame

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

Title

Progression Free Survival

Time Frame

Up to 5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer Measureable disease per response evaluation criteria (RECIST) v1.1 Prior bevacizumab Age > or = 21 years Adequate organ and marrow function 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. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 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. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease. Subjects with brain metastases Subjects with leptomeningial disease or neoplasms in the last 5 years Blood pressure >140/80 Significant intercurrent illness that will limit the patient's ability to participate in the study Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract. 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 Pregnant or nursing women New York Heart Association Classification II, III, or IV Inability to comply with study and follow up procedure

Facility Information:

Facility Name

University of Colorado, Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

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

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Levine Cancer Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

The University of Pennsylvania Health System

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

The University of Texas, MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35439029

Citation

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.

Results Reference

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

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