Advanced Relapsed TumorsPhase 1NCT02482441
A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10
A Phase 1 study testing OMP-131R10 and FOLFIRI in people with Advanced Relapsed Tumors and Refractory Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 7 sites in United States.
Trial summary
This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Relapsed Tumors, Refractory Solid Tumors
- What is being tested?
- OMP-131R10 and FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Jul 2015to 28 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for the study:
- Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any remaining standard therapy.
- Age ≥18 years
- ECOG performance status 0 or 1 (see Appendix B)
- Must have evaluable disease per RECIST 1.1. (see Appendix C)
- Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either archived or fresh core or punch needle biopsied at study entry (two fresh cores/punches preferred whenever possible).
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- Must have received their last anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy at least 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, from initiation of study treatment.
- Platelets >100,000/mL without transfusions in the past 7 days
- Total bilirubin within 1.5x institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) <3 X institutional ULN
- Patients with documented liver metastases: AST (SGOT) and/or ALT (SGPT) ≤ 5 × ULN
- Albumin ≥ 3.0 g/dL
- Creatinine <1.5 X institutional ULN OR
- Creatinine clearance >50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
Who cannot join
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Currently receiving any therapeutic treatment for their malignancy including other investigational agents
- Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement except for individuals who have previously treated CNS metastases, are asymptomatic, and have no requirement for a corticosteroid dose (indicated to reduce brain edema) that is equivalent to a prednisone dose of >10mg orally per day or anti-seizure medication for at least 4 weeks prior to first dose of study drug.
- History of a Grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women or nursing women
- Subjects with congestive heart failure with New York Heart Association Classification III, or IV (see Appendix D)
- Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado Hospital Anschulz Cancer Pavilion
Aurora, Colorado, 80045
Massachusetts General Hospital, Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Duke University
Durham, North Carolina, 27710
M.D. Anderson Cancer Center
Houston, Texas, 77030
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale
New Haven, Connecticut, 06520-8028
UCSF
San Francisco, California, 95115
About this study
Official title: A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 in Advanced Solid Tumors and in Combination With FOLFIRI for Patients With Previously Treated Metastatic Colorectal Cancer
This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
Read the detailed description
The Phase 1a portion of the study in subjects with advanced solid tumors will consist of a dose escalation part followed by a dose-expansion cohort. OMP-131R10 will be administered IV on the first day of each 14-day cycle.
Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
The Phase 1b portion of the study will be conducted in subjects with metastatic colorectal cancer whose tumors have progressed after at least 1 line of therapy for metastatic disease.
Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
- Conditions
- Advanced Relapsed Tumors, Refractory Solid Tumors
- Being tested
- OMP-131R10, FOLFIRI
- Keywords
- Advanced Solid Tumors and in Combination, FOLFIRI for Patients with Previously Treated Metastatic, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMP-131R10Drug
Also called OMP-131R10, IgG1 humanized monoclonal antibody
There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
FOLFIRIDrug
Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| OMP-131R10 intravenous (in the vein) infusions | Experimental | OMP-131R10 will be administered IV on the first day of each 14-day cycle. Receives: Drug: OMP-131R10; Drug: FOLFIRI |
| FOLFIRI (5-FU, irinotecan, leucovorin). | Experimental | dosing continues up to the 20 mg/kg dose level Receives: Drug: OMP-131R10; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.
Measured: DLTs during the evaluation (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start16 Jul 2015
- Primary completion26 Jan 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Relapsed TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482441
- Sponsor's protocol ID
- 131R10-001
- Status last verified
- Aug 2020
- First submitted
- 19 Jun 2015
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 in Advanced Solid Tumors and in Combination With FOLFIRI for Patients With Previously Treated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02482441
- Acronym / sponsor ID
- 131R10-001
- Conditions
- Advanced Relapsed Tumors, Refractory Solid Tumors
- Keywords
- Advanced Solid Tumors and in Combination, FOLFIRI for Patients with Previously Treated Metastatic, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
Detailed description
The Phase 1a portion of the study in subjects with advanced solid tumors will consist of a dose escalation part followed by a dose-expansion cohort. OMP-131R10 will be administered IV on the first day of each 14-day cycle.
Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
The Phase 1b portion of the study will be conducted in subjects with metastatic colorectal cancer whose tumors have progressed after at least 1 line of therapy for metastatic disease.
Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMP-131R10 intravenous (in the vein) infusions | Experimental | Drug: OMP-131R10, Drug: FOLFIRIOMP-131R10 will be administered IV on the first day of each 14-day cycle. |
| FOLFIRI (5-FU, irinotecan, leucovorin). | Experimental | Drug: OMP-131R10, Drug: FOLFIRIdosing continues up to the 20 mg/kg dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any remaining standard therapy.
- Age ≥18 years
- ECOG performance status 0 or 1 (see Appendix B)
- Must have evaluable disease per RECIST 1.1. (see Appendix C)
- Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either archived or fresh core or punch needle biopsied at study entry (two fresh cores/punches preferred whenever possible).
Key exclusion criteria (8 listed)
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Currently receiving any therapeutic treatment for their malignancy including other investigational agents
- Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement except for individuals who have previously treated CNS metastases, are asymptomatic, and have no requirement for a corticosteroid dose (indicated to reduce brain edema) that is equivalent to a prednisone dose of >10mg orally per day or anti-seizure medication for at least 4 weeks prior to first dose of study drug.
- History of a Grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMP-131R10Also: OMP-131R10, IgG1 humanized monoclonal antibodyThere are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity. | Drug | FOLFIRI (5-FU, irinotecan, leucovorin)., OMP-131R10 intravenous (in the vein) infusions |
| FOLFIRITreatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen. | Drug | FOLFIRI (5-FU, irinotecan, leucovorin)., OMP-131R10 intravenous (in the vein) infusions |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: DLTs during the evaluation (28 days)
Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMP-131R10 and FOLFIRI in people with Advanced Relapsed Tumors and Refractory Solid Tumors, 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 14 inclusion and 8 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 11 Aug 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 (DLTs) (time frame: DLTs during the evaluation (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2020.