Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT01471964
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MLN8237 and Erlotinib — DRUG
    Erlotinib pills once every day and MLN8237 pills twice every day, day 1-7 of every 21 days

Study Details

This phase I/II trial studies the side effects and the best dose of MLN8237 when given together with erlotinib hydrochloride and to see how well it works in treating patients with recurrent locally advanced or metastatic non-small cell lung cancer (NSCLC). MLN8237 and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

First listed
Nov 16, 2011
Start date
Oct 20, 2011
Status verified
May 2018
Primary completion
Feb 7, 2017
Completion
Apr 10, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MLN8237 and Erlotinib
    Phase I Erlotinib 100 mg PO daily\* + MLN8237 30 mg PO BID (days 1 - 7), escalating to Erlotinib 150mg PO daily + MLN8237 starting at 30mg PO BID days 1-7, escalating to 40mg BID (days 1 - 7) , then 50mg BID (days 1 - 7). Phase II Erlotinib 150mg PO daily + MLN8237 at MTD from phase I.

Primary Outcome Measure

Safety and tolerability of the combination treatment (Phase I) [ Time Frame: Participants will be followed for the duration of treatment (up to 2 years) through 30 days of completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Philadelphia, PA

By research site
Fox Chase Cancer Center· Philadelphia, PA

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