Advanced Solid TumorsPhase 1NCT01520389
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
A Phase 1 study testing MM-151 and MM-151 + irinotecan in people with Advanced Solid Tumors and Colorectal Cancer, run by Merrimack Pharmaceuticals at 4 sites in United States.
Trial summary
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Colorectal Cancer, Squamous Cell Head and Neck Cancer
- What is being tested?
- MM-151 and MM-151 + irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to Jan 2016
- 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
- Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
- Patients must be > 18 years of age
- Patients of their legal representatives must be able to understand and sign an informed consent form
- Patients must have evaluable or measurable tumor(s)
- Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy
- Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-151 (an effective form of contraception is an oral contraceptive or a double barrier method)
Who cannot join
- Patients for whom potentially curative antineoplastic therapy is available
- Patients who are pregnant or lactating
- Patients with an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled.)
- Patients with untreated and/or symptomatic CNS malignancies (primary or metastatic); patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Denver
Aurora, Colorado, 80045
Roswell Park Cancer Institute
Buffalo, New York, 14263
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.
Read the detailed description
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.
- Conditions
- Advanced Solid Tumors, Colorectal Cancer, Squamous Cell Head and Neck Cancer, Non Small Cell Lung Cancer, Triple Negative Breast Cancer
- Being tested
- MM-151, MM-151 + irinotecan
- Keywords
- cancer, solid tumors, oncology, Phase I, EGFR, EGF receptor (ErbB1), irinotecan
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-151Drug
MM-151
MM-151 + irinotecanDrug
Also called camptosar
MM-151 + irinotecan
| Study group | Role | What they receive |
|---|---|---|
| MM-151 Dose Escalation | Experimental | MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks Receives: Drug: MM-151 |
| MM-151 Expansion in KRAS wild type colorectal cancer | Experimental | MM-151 given weekly Receives: Drug: MM-151 |
| MM-151 + irinotecan | Experimental | MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks Receives: Drug: MM-151 + irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.
Measured: Two years
Secondary outcomes (3)
Number of dose limiting toxicities (DLTs) within a cohort
Measured: 2 years
Adverse event profile of MM-151 alone and in combination with irinotecan
Measured: 2 years
Objective response to MM-151 alone and in combination with irinotecan based on RECIST
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520389
- Sponsor's protocol ID
- MM-151-01-01-01
- Status last verified
- Mar 2018
- First submitted
- 13 Jan 2012
- Last updated
- 21 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01520389
- Acronym / sponsor ID
- MM-151-01-01-01
- Conditions
- Advanced Solid Tumors, Colorectal Cancer, Squamous Cell Head and Neck Cancer, Non Small Cell Lung Cancer, Triple Negative Breast Cancer
- Keywords
- cancer, solid tumors, oncology, Phase I, EGFR, EGF receptor (ErbB1), irinotecan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jan 2012 (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 study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.
Detailed description
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MM-151 Dose Escalation | Experimental | Drug: MM-151MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks |
| MM-151 Expansion in KRAS wild type colorectal cancer | Experimental | Drug: MM-151MM-151 given weekly |
| MM-151 + irinotecan | Experimental | Drug: MM-151 + irinotecanMM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
- Patients must be > 18 years of age
- Patients of their legal representatives must be able to understand and sign an informed consent form
- Patients must have evaluable or measurable tumor(s)
- Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy
Key exclusion criteria (4 listed)
- Patients for whom potentially curative antineoplastic therapy is available
- Patients who are pregnant or lactating
- Patients with an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled.)
- Patients with untreated and/or symptomatic CNS malignancies (primary or metastatic); patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
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 |
|---|---|---|
| MM-151MM-151 | Drug | MM-151 Dose Escalation, MM-151 Expansion in KRAS wild type colorectal cancer |
| MM-151 + irinotecanAlso: camptosarMM-151 + irinotecan | Drug | MM-151 + irinotecan |
Primary outcome
Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.
Time frame: Two years
3 secondary outcomes
Number of dose limiting toxicities (DLTs) within a cohort
Time frame: 2 years
Adverse event profile of MM-151 alone and in combination with irinotecan
Time frame: 2 years
Objective response to MM-151 alone and in combination with irinotecan based on RECIST
Time frame: 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 21 Mar 2018.
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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.
4 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 MM-151 and MM-151 + irinotecan in people with Advanced Solid Tumors and Colorectal Cancer, run by Merrimack Pharmaceuticals at 4 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 6 inclusion and 4 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 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies. (time frame: Two years). 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 21 Mar 2018.