Solid TumorsPhase 1NCT01447225

Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

A Phase 1 study testing MM-121, Carboplatin and Pemetrexed in people with Solid Tumors, run by Merrimack Pharmaceuticals at 5 sites in 2 countries.

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

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: MM-121, Carboplatin and Pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 5 sitesin 2 countries
Study dates: Oct 2011to Jan 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Advanced-stage solid tumors
≥ 18 years of age
Adequate liver and kidney function

Who cannot join

Any other active malignancy
No known HIV, Hepatitis C or B

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

Study site
Buffalo, New York, 14263
Study site
Cincinnati, Ohio, 45267
Study site
Lafayette, Indiana, 47905
Study site
Philadelphia, Pennsylvania, 19111

Other trials in United States

France1 site

Study site
Villejuif

Other trials in France

About this study

Official title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Read the detailed description

This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.

Conditions: Solid Tumors
Being tested: MM-121, Carboplatin, Pemetrexed, Cabazitaxel, Gemcitabine
Keywords: Advanced-stage, Solid Tumors, MM-121, Carboplatin, Pemetrexed, Gemcitabine, Cabazitaxel, ErbB3, Phase I, Cancer
Medical subject headings: Neoplasms

What participants receive

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

MM-121Drug
Also called Seribantumab, SAR256212
MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
CarboplatinDrug
administered at AUC 6
PemetrexedDrug
Also called ALIMTA
administered IV at 500 mg/m2
CabazitaxelDrug
Also called Jevtana
administered IV at 20 mg/m2 or 25 mg/m2
GemcitabineDrug
Also called Gemzar
administered IV at 1000 mg/m2 or 1250 mg/m2

Study groups in NCT01447225
Study group	Role	What they receive
MM-121 plus Gemcitabine	Experimental	escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle Receives: Drug: MM-121; Drug: Gemcitabine
MM-121 plus Carboplatin	Experimental	carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle Receives: Drug: MM-121; Drug: Carboplatin
MM-121 plus Pemetrexed	Experimental	pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle Receives: Drug: MM-121; Drug: Pemetrexed
MM-121 plus Cabazitaxel	Experimental	escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle Receives: Drug: MM-121; Drug: Cabazitaxel

What is being measured

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

To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies
Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin
Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.
Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks
To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies
To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.
Measured: From date of first dose to 30 days after termination, the longest 88.1 weeks

Secondary outcomes (4)

Objective Response Rate
To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.
Measured: patients were assessed for response during their time on study, the longest of which was 88.1 weeks
Pharmacokinetics
Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg).
Measured: Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion
Pharmacokinetics (AUClast)
Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2).
Measured: Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion
Immunogenicity
Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).
Measured: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction

Timeline

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

Oct 2011Jan 2014

First posted6 Oct 2011 (estimated)
Study startOct 2011
Primary completionNov 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01447225
Sponsor's protocol ID: MM-121-06-01-06 (TCD11694)
Status last verified: Sep 2016
First submitted: 3 Oct 2011
Last updated: 14 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01447225
Acronym / sponsor ID: MM-121-06-01-06 (TCD11694)
Conditions: Solid Tumors
Keywords: Advanced-stage, Solid Tumors, MM-121, Carboplatin, Pemetrexed, Gemcitabine, Cabazitaxel, ErbB3
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: Oct 2011
Primary completion: Nov 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 6 Oct 2011 (estimated)
Results: Posted 14 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
MM-121 plus Gemcitabine	Experimental	Drug: MM-121, Drug: Gemcitabineescalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle
MM-121 plus Carboplatin	Experimental	Drug: MM-121, Drug: Carboplatincarboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121 plus Pemetrexed	Experimental	Drug: MM-121, Drug: Pemetrexedpemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle
MM-121 plus Cabazitaxel	Experimental	Drug: MM-121, Drug: Cabazitaxelescalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Advanced-stage solid tumors
≥ 18 years of age
Adequate liver and kidney function

Key exclusion criteria (2 listed)

Any other active malignancy
No known HIV, Hepatitis C or B

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-121Also: Seribantumab, SAR256212MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV	Drug	MM-121 plus Cabazitaxel, MM-121 plus Carboplatin, MM-121 plus Gemcitabine, MM-121 plus Pemetrexed
Carboplatinadministered at AUC 6	Drug	MM-121 plus Carboplatin
PemetrexedAlso: ALIMTAadministered IV at 500 mg/m2	Drug	MM-121 plus Pemetrexed
CabazitaxelAlso: Jevtanaadministered IV at 20 mg/m2 or 25 mg/m2	Drug	MM-121 plus Cabazitaxel
GemcitabineAlso: Gemzaradministered IV at 1000 mg/m2 or 1250 mg/m2	Drug	MM-121 plus Gemcitabine

Primary outcome

To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1
To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose. Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3
To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies
Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks
To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.

4 secondary outcomes

Objective Response Rate
Time frame: patients were assessed for response during their time on study, the longest of which was 88.1 weeks
Pharmacokinetics
Time frame: Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion
Pharmacokinetics (AUClast)
Time frame: Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion
Immunogenicity
Time frame: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction

Results and safety

Results posted to the registry on 14 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MM-121 Plus Gemcitabine: Cohort 1	3	3
MM-121 Plus Gemcitabine: Cohort 2	8	8
MM-121 Plus Carboplatin: Cohort 1	5	5
MM-121 Plus Carboplatin: Cohort 2	3	3
MM-121 Plus Carboplatin: Cohort 3	3	3
MM-121 Plus Pemetrexed: Cohort 1	3	3
MM-121 Plus Pemetrexed: Cohort 2	7	7
MM-121 Plus Cabazitaxel: Cohort 1	4	4
MM-121 Plus Cabazitaxel: Cohort 2	3	3
MM-121 Plus Cabazitaxel: Cohort 3	4	4

Primary outcome: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies

Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks. Number. Unit: participants reporting adverse events

Measure	MM-121 Plus Gemcitabine: Cohort 1 n = 3	MM-121 Plus Gemcitabine: Cohort 2 n = 8	MM-121 Plus Carboplatin: Cohort 1 n = 5	MM-121 Plus Carboplatin: Cohort 2 n = 3	MM-121 Plus Carboplatin: Cohort 3 n = 3	MM-121 Plus Pemetrexed: Cohort 1 n = 3	MM-121 Plus Pemetrexed: Cohort 2 n = 7	MM-121 Plus Cabazitaxel: Cohort 1 n = 4	MM-121 Plus Cabazitaxel: Cohort 2 n = 3	MM-121 Plus Cabazitaxel: Cohort 3 n = 4
Value	3	8	5	3	3	3	7	4	3	4

Primary outcome: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses

Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks. Number. Unit: mg/kg

Measure	MM-121 Plus Gemcitabine n = 11	MM-121 Plus Carboplatin n = 11	MM-121 Plus Pemetrexed n = 10	MM-121 Plus Cabazitaxel n = 11
one-time loading dose	40	40	40	40
maintenance dose	20	20	20	20

Population analysed: Note: data provided below is for MM-121 doses only for the combination. Combination therapy MTDs are provided in separate endpoint measures.

Primary outcome: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine

Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks. Number. Unit: mg/m2

Measure	MM-121 + Gemcitabine n = 11
Value	1000

Population analysed: NOTE: Maximum tolerated dose is for the combination of gemcitabine and MM-121. MTD of MM-121 is provided in separate endpoint.

Primary outcome: To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin

Time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks. Number. Unit: target AUC (mg*min/mL)

Measure	MM-121 + Carboplatin n = 11
Value	5

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from a patient's first dose until 30 days after treatment termination. SAEs were collected from time of informed consent until 30 days after termination. If related, events could be reported at any time after termination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MM-121 Plus Gemcitabine	9 of 11 (81.8%)	11 of 11 (100%)	Not reported
MM-121 Plus Carboplatin	7 of 11 (63.6%)	11 of 11 (100%)	Not reported
MM-121 Plus Pemetrexed	3 of 10 (30%)	10 of 10 (100%)	Not reported
MM-121 Plus Cabazitaxel	2 of 11 (18.2%)	11 of 11 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Solid Tumors

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.

Victor Moyo, MD study director

Merrimack Pharmaceuticals

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MM-121, Carboplatin and Pemetrexed in people with Solid Tumors, run by Merrimack Pharmaceuticals at 5 sites in 2 countries.

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 3 inclusion and 2 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 14 Sep 2016. 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, France. 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?

Yes. Results are posted in the registry (first posted 14 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies (time frame: From date of first dose to 30 days after termination, the longest 88.1 weeks). The study lists 7 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 NCT01447225.

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 14 Sep 2016.