Metastatic Colorectal CancerPhase 1NCT03031691
A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
A Phase 1 study testing brontictuzumab and trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by OncoMed Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- brontictuzumab and trifluridine/tipiracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2017to Sep 2017
- 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
- Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
- ECOG performance status 0 or 1
Who cannot join
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
- Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug
- Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:
- Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
- Active peptic ulcer disease
- Known intraluminal metastatic lesion(s) with risk of bleeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Charleston
Charleston, South Carolina
Denver
Denver, Colorado
Miami
Miami, Florida
Nashville
Nashville, Tennessee
Sarasota
Sarasota, Florida
About this study
Official title: A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.
Read the detailed description
This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal 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 up to 24 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 34 patients will be enrolled in this study at approximately 5 study centers in the United States.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- brontictuzumab, trifluridine/tipiracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brontictuzumabDrug
Also called OMP-52M51
starting dose of 1.5mg/kg administered intravenously (IV)
trifluridine/tipiracilDrug
| Study group | Role | What they receive |
|---|---|---|
| Brontictuzumab and trifluridine/tipiracil | Experimental | Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label. Receives: Drug: brontictuzumab; Drug: trifluridine/tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with adverse events
Measured: up to approximately 2 years
Percentage of patients with dose limiting toxicities
Measured: 28 days
Percentage of patients with anti-brontictuzumab antibodies
Measured: up to approximately 2 years
Secondary outcomes (4)
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Measured: approximately 2 years
Changes in number of circulating tumor cells
Measured: approximately 2 years
Overall survival
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031691
- Sponsor's protocol ID
- 52M51-003
- Status last verified
- Aug 2020
- First submitted
- 13 Jan 2017
- 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 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03031691
- Acronym / sponsor ID
- 52M51-003
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Jan 2017 (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.
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.
Detailed description
This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal 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 up to 24 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 34 patients will be enrolled in this study at approximately 5 study centers in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brontictuzumab and trifluridine/tipiracil | Experimental | Drug: brontictuzumab, Drug: trifluridine/tipiracilBrontictuzumab will be administered per protocol and trifluridine/tipiracil per label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
- ECOG performance status 0 or 1
Key exclusion criteria (7 listed)
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
- Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug
- Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:
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 |
|---|---|---|
| brontictuzumabAlso: OMP-52M51starting dose of 1.5mg/kg administered intravenously (IV) | Drug | Brontictuzumab and trifluridine/tipiracil |
| trifluridine/tipiracil | Drug | Brontictuzumab and trifluridine/tipiracil |
Primary outcome
Percentage of patients with adverse events
Time frame: up to approximately 2 years
Percentage of patients with dose limiting toxicities
Time frame: 28 days
Percentage of patients with anti-brontictuzumab antibodies
Time frame: up to approximately 2 years
4 secondary outcomes
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Time frame: approximately 2 years
Changes in number of circulating tumor cells
Time frame: approximately 2 years
Overall survival
Time frame: approximately 2 years
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.
5 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 brontictuzumab and trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by OncoMed Pharmaceuticals, Inc. at 5 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 2 inclusion and 7 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 5 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?
Percentage of patients with adverse events (time frame: up to approximately 2 years). The study lists 3 primary outcomes in all. 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.