A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Information source: Merrimack Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer; NSCLC; Adenocarcinoma; Squamous Cell Carcinoma; Heregulin; Large Cell Carcinoma
Intervention: MM-121 (Drug); Docetaxel (Drug); Pemetrexed (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merrimack Pharmaceuticals Official(s) and/or principal investigator(s): MM-121 Program Medical Director, MD, Study Director, Affiliation: Merrimack Pharmaceuticals
Summary
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel
or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to PFS in
patients with heregulin-positive NSCLC.
Clinical Details
Official title: A Phase 2 Study of MM-121 in Combination With Docetaxel or Pemetrexed Versus Docetaxel or Pemetrexed Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-free survival
Secondary outcome: Overall SurvivalObjective Response Rate Rate of adverse events reported with the combination of MM-121 with docetaxel or pemetrexed Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel or pemetrexed, specifically focusing on "Area under the plasma concentration versus time curve (AUC)".
Detailed description:
This study is a randomized, open-label, international, multi-center, phase 2 study in
patients with Heregulin-positive NSCLC that have progressed following no more than two
systemic therapies for locally advanced or metastatic disease, of which one must have been a
platinum based doublet therapy. All patients will initially be screened for heregulin
status. Eligible patients will be randomized to receive MM-121 in combination with
investigator's choice of either docetaxel or pemetrexed versus docetaxel or pemetrexed
alone.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with a diagnosis of cytologically or histologically confirmed NSCLC with
either metastatic disease (stage IV) or Stage IIIB disease not amenable to surgery
with curative intent
- Failed one prior platinum-based regimen and has not received more than 2 prior
systemic therapies for primary or recurrent disease
- Tissue submitted for HRG-biomarker testing
- ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
- Known ALK mutation
- Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
- Received >2 prior systemic anti-cancer drug regimen for locally advanced disease
- CTCAE grade 3 or higher peripheral neuropathy
- Symptomatic CNS metastases or CNS metastases requiring steroids
- Any other active malignancy requiring systemic therapy
- Clinically significant cardiac disease
Locations and Contacts
Chicago, Illinois 60611, United States; Not yet recruiting Amy Hoyer, Phone: 312-695-1341, Email: amy.hoyer@northwestern.edu
Lafayette, Indiana, United States; Recruiting Wael Harb, MD, Phone: 765-446-5111, Email: wharb@horizonbioadvance.com
Additional Information
Starting date: February 2015
Last updated: March 6, 2015
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