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EGFR Mutated EGFR TKI Naive Metastatic NSCLCPhase 1NCT02206763

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)

A Phase 1 study testing Momelotinib (MMB) and Erlotinib in people with EGFR Mutated EGFR TKI Naive Metastatic NSCLC, run by Sierra Oncology LLC - a GSK company at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Momelotinib (MMB) and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesUnited States
Study dates
16 Oct 2014to 16 Feb 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Duarte, California

  • Study site

    Palo Alto, California

  • Study site

    Whittier, California

Other trials in United States

About this study

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)

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.

Being tested
Momelotinib (MMB), Erlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Momelotinib (MMB)Drug

    Also called GS-0387, CYT387

    Tablet(s) administered orally once or twice daily

  • ErlotinibDrug

    Also called Tarceva®

    Tablet(s) administered orally once daily.

Study groups in NCT02206763
Study groupRoleWhat they receive
Momelotinib (MMB)+erlotinibExperimentalParticipants will receive momelotinib (MMB) plus erlotinib.
Receives: Drug: Momelotinib (MMB); Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLTs)

    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.

    Measured: Up to 28 days

  2. Safety as Assessed by the Incidence of Adverse Events (AEs)

    Measured: Up to 2 years plus 30 days

  3. Safety as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Graded Lab Abnormalities (including Chemistry, Coagulation, Hematology, and Urinalysis)

    Measured: Up to 2 years plus 30 days

  4. Change from Baseline in Vital Signs

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Progression-Free Survival

    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.

    Measured: Until disease progression (up to 2 years)

  2. Overall Survival

    Overall survival is defined as the interval from first dose date of study drug (MMB/erlotinib) to death from any cause.

    Measured: Until disease progression (up to 2 years)

  3. Overall Response Rate

    Overall response rate is defined as the proportion of participants who achieve a complete response or partial response.

    Measured: Until disease progression (up to 2 years)

  4. Pharmacokinetic (PK) Parameter: Cmax of momelotinib (MMB)

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Predose and up to 24 hours postdose

  5. PK Parameter: AUCtau of momelotinib (MMB)

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

    Measured: Predose and up to 24 hours postdose

  6. PK Parameter: Cmax of Erlotinib

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Predose and up to 24 hours postdose

  7. PK Parameter: AUCtau of Erlotinib

    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

    Measured: Predose and up to 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2014 (estimated)
  2. Study start16 Oct 2014
  3. Primary completion12 Jan 2017
  4. Study completion16 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02206763
Sponsor's protocol ID
GS-US-370-1298
Status last verified
Jan 2019
First submitted
30 Jul 2014
Last updated
1 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Padda SK, Reckamp KL, Koczywas M, Neal JW, Kawashima J, Kong S, Huang DB, Kowalski M, Wakelee HA. A phase 1b study of erlotinib and momelotinib for the treatment of EGFR-mutated, tyrosine kinase inhibitor-naive metastatic non-small cell lung cancer. Cancer Chemother Pharmacol. 2022 Jan;89(1):105-115. doi: 10.1007/s00280-021-04369-0. Epub 2021 Nov 13.

    PubMed 34773474

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Momelotinib (MMB) and Erlotinib in people with EGFR Mutated EGFR TKI Naive Metastatic NSCLC, run by Sierra Oncology LLC - a GSK company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02206763, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.

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