Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)

Conditions

• EGFR Mutated EGFR TKI Naive Metastatic NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Momelotinib (MMB) — DRUG
  Tablet(s) administered orally once or twice daily
• Erlotinib — DRUG
  Tablet(s) administered orally once daily.

Study Details

This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung cancer (NSCLC). Participants will be sequentially enrolled to receive progressively increasing doses of momelotinib (MMB) in combination with erlotinib. Escalation of momelotinib (MMB) doses will proceed to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT) during the first 28 days of combined erlotinib and momelotinib (MMB) treatment. There will be four dose levels and each treatment cycle will consist of 28 days.

Key Dates

First listed

Aug 1, 2014

Start date

Oct 16, 2014

Status verified

Jan 2019

Primary completion

Jan 12, 2017

Completion

Feb 16, 2017

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Momelotinib (MMB)+erlotinib
  Participants will receive momelotinib (MMB) plus erlotinib.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Locations (3)