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Cancer OvariesPhase 1NCT03030287

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

A Phase 1 study testing OMP-305B83 and Paclitaxel in people with Cancer Ovaries and Cancer Peritoneal, run by OncoMed Pharmaceuticals, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older, women only
What is being tested?
OMP-305B83 and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
7 sitesUnited States
Study dates
Dec 2016to Apr 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Colorado, Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • The University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

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

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Read the 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)..

Being tested
OMP-305B83, Paclitaxel
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMP-305B83Drug

    Also called bispecific monoclonal antibody

    intravenous (in the vein) infusion

  • PaclitaxelDrug

    administered intravenously

Study groups in NCT03030287
Study groupRoleWhat they receive
OMP-305B83 plus paclitaxelExperimentalNot described
Receives: Drug: OMP-305B83; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (5)

  1. 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.

    Measured: Through study completion, an average of 6 months

  2. 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

    Measured: Through study completion, an average of 6 months

  3. Response Rate assessed by RECIST criteria 1.1

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

  4. Response Rate assessed by CA-125 criteria

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

  5. Progression Free Survival

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionApr 2020
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030287
Sponsor's protocol ID
B83-002
Status last verified
Sep 2020
First submitted
13 Jan 2017
Last updated
3 Sep 2020
Results posted
No

Publications

  • 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.

    PubMed 35439029

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OMP-305B83 and Paclitaxel in people with Cancer Ovaries and Cancer Peritoneal, run by OncoMed Pharmaceuticals, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLT) (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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