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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 Survival

Objective 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

Page last updated: August 20, 2015

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