A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer

ClinicalTrials.gov ID

NCT00994123

Acronym / sponsor ID

MM-121-01-101

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, Lung Cancer, Erlotinib, Tarceva, MM-121

Phase

Phase 1/2

Study type

Interventional

Recruitment status

Completed

Enrolment

162 participants (actual)

Lead sponsor

Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)

Study start

Feb 2010

Primary completion

Nov 2014 (actual)

Study completion

Jun 2015 (actual)

First posted

14 Oct 2009 (estimated)

Results

Posted 22 Aug 2016

Clinical summary

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

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

3

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.

   Time frame: From date of first dose to 30 days after termination, the longest 175 weeks

   To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. 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.

2. Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities

   Time frame: From date of first dose to 30 days after termination, the longest 175 weeks

   Using a 3+3 dose escalation model, the maximum tolerated dose 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 the 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 used as the recommended Phase 2 dose.

3. Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination

   Time frame: Time from first dose to date of progression, with a median of 8.1 weeks

   This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

38 sites in 6 countries: see every site and its status.