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
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)..
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of dose limiting toxicities (DLT)
Secondary Outcome
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.
Condition
Cancer Ovaries
Intervention
OMP-305B83
Study Arms / Comparison Groups
OMP-305B83 plus paclitaxel
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
44
Start Date
December 2016
Completion Date
April 2020
Primary Completion Date
April 2020
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
Gender
Female
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03030287
Organization ID
B83-002
Responsible Party
Sponsor
Study Sponsor
OncoMed Pharmaceuticals, Inc.
Study Sponsor
, ,
Verification Date
September 2020