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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01447225
• Date of registration: 03/10/2011
• Prospective Registration: No
• Primary sponsor: Merrimack Pharmaceuticals
• Public title: Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
• Scientific title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors
• Date of first enrolment: October 2011
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01447225
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

France, United States

Contacts

• Name: Victor Moyo, MD
• Affiliation: Merrimack Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Advanced-stage solid tumors

- = 18 years of age

- Adequate liver and kidney function

Exclusion Criteria:

- Any other active malignancy

- No known HIV, Hepatitis C or B



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumors

Intervention(s)

Drug: Pemetrexed

Drug: Gemcitabine

Drug: MM-121

Drug: Carboplatin

Drug: Cabazitaxel

Primary Outcome(s)

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 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]

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]

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]

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]

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]

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]

Secondary Outcome(s)

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]

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]

Objective Response Rate [Time Frame: patients were assessed for response during their time on study, the longest of which was 88.1 weeks]

Secondary ID(s)

MM-121-06-01-06 (TCD11694)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 14/09/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01447225