Clinical Trial: NCT02206763 - My Cancer Genome

NCT02206763

Description:

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.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Terminated

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02206763

Trial Eligibility

Document

Title

Brief Title: 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)
Official Title: A Phase 1b Study of Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naïve Metastatic Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

ORG STUDY ID: GS-US-370-1298
NCT ID: NCT02206763

Conditions

EGFR Mutated EGFR TKI Naive Metastatic NSCLC

Interventions

Drug	Synonyms	Arms
Momelotinib (MMB)	GS-0387, CYT387	Momelotinib (MMB)+erlotinib
Erlotinib	Tarceva®	Momelotinib (MMB)+erlotinib

Purpose

Trial Arms

Name	Type	Description	Interventions
Momelotinib (MMB)+erlotinib	Experimental	Participants will receive momelotinib (MMB) plus erlotinib.	Momelotinib (MMB) Erlotinib

Eligibility Criteria

        Key Inclusion Criteria:

          -  Metastatic NSCLC with documented EGFR exon 19 deletion or exon 21 (L858R) substitution
             mutation

          -  Treatment naive OR one prior standard chemotherapy that is platinum-based

          -  Adequate organ function defined as follows:

               -  Hepatic: Total bilirubin < upper limit of the normal range (ULN); aspartate
                  transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN

               -  Hematological: absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥
                  100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL

               -  Renal: Serum creatinine < ULN OR calculated creatinine clearance (CLcr) of ≥ 60
                  ml/min

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

        Key Exclusion Criteria:

          -  Known positive status for human immunodeficiency virus (HIV)

          -  Chronic active or acute viral hepatitis A, B, or C infection (testing required for
             hepatitis B and C)

          -  Presence of > Grade 1 peripheral neuropathy

          -  Symptomatic leptomeningeal, brain metastases, or spinal cord compression.

          -  History of interstitial pneumonitis

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Incidence of Dose Limiting Toxicities (DLTs)
Time Frame:	Up to 28 days
Safety Issue:
Description:	Dose limiting toxicities refer to toxicities experienced during the first 28 days of combined erlotinib and momelotinib (MMB) treatment that have been judged to be clinically significant and related to study treatment.

Secondary Outcome Measures

Measure:	Progression-Free Survival
Time Frame:	Until disease progression (up to 2 years)
Safety Issue:
Description:	Progression-free survival is defined as the interval from first dose date of study drug (MMB/erlotinib) to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1.

Measure:	Overall Survival
Time Frame:	Until disease progression (up to 2 years)
Safety Issue:
Description:	Overall survival is defined as the interval from first dose date of study drug (MMB/erlotinib) to death from any cause.

Measure:	Overall Response Rate
Time Frame:	Until disease progression (up to 2 years)
Safety Issue:
Description:	Overall response rate is defined as the proportion of participants who achieve a complete response or partial response.

Measure:	Pharmacokinetic (PK) Parameter: Cmax of momelotinib (MMB)
Time Frame:	Predose and up to 24 hours postdose
Safety Issue:
Description:	Cmax is defined as the maximum observed concentration of drug.

Measure:	PK Parameter: AUCtau of momelotinib (MMB)
Time Frame:	Predose and up to 24 hours postdose
Safety Issue:
Description:	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Measure:	PK Parameter: Cmax of Erlotinib
Time Frame:	Predose and up to 24 hours postdose
Safety Issue:
Description:	Cmax is defined as the maximum observed concentration of drug.

Measure:	PK Parameter: AUCtau of Erlotinib
Time Frame:	Predose and up to 24 hours postdose
Safety Issue:
Description:	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Terminated
Lead Sponsor:	Sierra Oncology, Inc.

Last Updated

February 1, 2019

Clinical Trials /

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)