Breast CancerPhase 1NCT01304797
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
A Phase 1 study testing MM-302 Monotherapy, MM-302 in combination with trastuzumab and MM-302 in combination with trastuzumab q3w in people with Breast Cancer, run by Merrimack Pharmaceuticals at 5 sites in United States.
Trial summary
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MM-302 Monotherapy, MM-302 in combination with trastuzumab and MM-302 in combination with trastuzumab q3w
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2011to Jan 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
- Locally advanced/unresectable or metastatic breast cancer
- Eighteen years of age or above
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score of 0 or 1
- Adequate bone marrow, hepatic, renal and cardiac function
- Willing 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-302
Who cannot join
- Patients for whom potentially curative anticancer therapy is available
- Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
- Received other recent antitumor therapy
- Pregnant or breast feeding
- Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Center
Boston, Massachusetts
Karmanos Cancer Center
Detroit, Michigan
University of Indiana
Indianapolis, Indiana
University of California San Francisco
San Francisco, California
Washington University
St Louis, Missouri
About this study
Official title: A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- MM-302 Monotherapy, MM-302 in combination with trastuzumab, MM-302 in combination with trastuzumab q3w, MM-302 in combination with trastuzumab and cyclophosphamide
- Keywords
- MM302, Breast Cancer, Locally advanced/unresectable, metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-302 MonotherapyDrug
Escalating doses of MM-302 as a single agent
MM-302 in combination with trastuzumabDrug
Also called Herceptin
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
MM-302 in combination with trastuzumab q3wDrug
Also called herceptin
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
MM-302 in combination with trastuzumab and cyclophosphamideDrug
Also called herceptin, cytoxan; neosar
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| MM-302 | Experimental | Not described Receives: Drug: MM-302 Monotherapy |
| MM-302 in Combination with Trastuzumab | Experimental | Not described Receives: Drug: MM-302 in combination with trastuzumab |
| MM-302 in Combination with Trastuzumab q3w | Experimental | Not described Receives: Drug: MM-302 in combination with trastuzumab q3w |
| MM-302 in Combination with Trastuzumab and Cyclophosphamide | Experimental | Not described Receives: Drug: MM-302 in combination with trastuzumab and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity and the number of adverse events related to escalating doses of the MM-302.
Measured: 12 months
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
Measured: 12 months
Secondary outcomes (3)
Objective response rate of MM-302
Measured: 12 months
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
Measured: 12 months
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2016
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304797
- Sponsor's protocol ID
- MM-302-02-01-01
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2011
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee H, Shields AF, Siegel BA, Miller KD, Krop I, Ma CX, LoRusso PM, Munster PN, Campbell K, Gaddy DF, Leonard SC, Geretti E, Blocker SJ, Kirpotin DB, Moyo V, Wickham TJ, Hendriks BS. 64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer. Clin Cancer Res. 2017 Aug 1;23(15):4190-4202. doi: 10.1158/1078-0432.CCR-16-3193. Epub 2017 Mar 15.
PubMed 28298546
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01304797
- Acronym / sponsor ID
- MM-302-02-01-01
- Conditions
- Breast Cancer
- Keywords
- MM302, Breast Cancer, Locally advanced/unresectable, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 25 Feb 2011 (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-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MM-302 | Experimental | Drug: MM-302 Monotherapy |
| MM-302 in Combination with Trastuzumab | Experimental | Drug: MM-302 in combination with trastuzumab |
| MM-302 in Combination with Trastuzumab q3w | Experimental | Drug: MM-302 in combination with trastuzumab q3w |
| MM-302 in Combination with Trastuzumab and Cyclophosphamide | Experimental | Drug: MM-302 in combination with trastuzumab and cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced/unresectable or metastatic breast cancer
- Eighteen years of age or above
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score of 0 or 1
Key exclusion criteria (7 listed)
- Patients for whom potentially curative anticancer therapy is available
- Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
- Received other recent antitumor therapy
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-302 MonotherapyEscalating doses of MM-302 as a single agent | Drug | MM-302 |
| MM-302 in combination with trastuzumabAlso: HerceptinEscalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule | Drug | MM-302 in Combination with Trastuzumab |
| MM-302 in combination with trastuzumab q3wAlso: herceptinEscalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule | Drug | MM-302 in Combination with Trastuzumab q3w |
| MM-302 in combination with trastuzumab and cyclophosphamideAlso: herceptin, cytoxan; neosarEscalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule | Drug | MM-302 in Combination with Trastuzumab and Cyclophosphamide |
Primary outcome
The severity and the number of adverse events related to escalating doses of the MM-302.
Time frame: 12 months
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
Time frame: 12 months
3 secondary outcomes
Objective response rate of MM-302
Time frame: 12 months
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
Time frame: 12 months
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Derived from this study: PubMed 28298546Lee H, Shields AF, Siegel BA, Miller KD, Krop I, Ma CX, LoRusso PM, Munster PN, Campbell K, Gaddy DF, Leonard SC, Geretti E, Blocker SJ, Kirpotin DB, Moyo V, Wickham TJ, Hendriks BS. 64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer. Clin Cancer Res. 2017 Aug 1;23(15):4190-4202. doi: 10.1158/1078-0432.CCR-16-3193. Epub 2017 Mar 15.
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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 MM-302 Monotherapy, MM-302 in combination with trastuzumab and MM-302 in combination with trastuzumab q3w in people with Breast Cancer, run by Merrimack Pharmaceuticals 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 7 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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?
Results are not available in the source record.
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?
The severity and the number of adverse events related to escalating doses of the MM-302. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01304797, 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 6 Jan 2017.