Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase

Conditions

• Relapsed Metastatic KRAS-Mutated Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Momelotinib (MMB) — DRUG
  Momelotinib (MMB) tablet(s) administered orally once or twice daily
• Trametinib — DRUG
  Trametinib tablet administered orally once daily

Study Details

This study is conducted in two phases. The Dose-finding Lead-in Phase, Part A, will evaluate the safety and determine the maximum tolerated dose (MTD) of momelotinib (MMB) when combined with trametinib. Once the MTD of momelotinib (MMB) is determined, the study will proceed to the Dose-finding Lead-in Phase, Part B, to determine the MTD of trametinib. After the MTD is established, the study may proceed to an expansion phase to determine the efficacy, safety, and tolerability of MMB combined with trametinib at the MTD in participants with kirsten rat sarcoma viral oncogene homolog (KRAS) mutated metastatic non-small cell lung cancer (NSCLC). Each treatment cycle will consist of 28 days and treatment will continue in the absence of disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment.

Key Dates

Start date

Mar 11, 2015

Status verified

Jan 2019

Primary completion

Jul 19, 2016

Completion

Feb 27, 2017

Study Design

Enrollment

21 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Momelotinib (MMB) dose escalation
  Participants will receive momelotinib (MMB) plus trametinib. Momelotinib (MMB) dose will increase to find the MTD.
• Experimental: Trametinib dose escalation
  Participants will receive momelotinib (MMB) plus trametinib. Trametinib dose will increase to find the MTD.
• Experimental: Momelotinib (MMB)+trametinib
  Expansion Phase: participants will receive momelotinib (MMB) plus trametinib for the duration of the study.

Primary Outcome Measure

For the Dose-finding Lead-in Phase, incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Locations (5)