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Non-small Cell Lung CancerPhase 1/2NCT02580708

Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 1/2 study testing Rociletinib and Trametinib in people with Non-small Cell Lung Cancer, run by Clovis Oncology, Inc. at 4 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

The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib when administered in combination with trametinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Rociletinib and Trametinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
4 sitesUnited States
Study dates
30 Sep 2015to 27 Jun 2016
Phase
Phase 1/2
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

  • Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation
  • Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC with EGFR activating mutation (excluding exon 20 insertion); measurable disease per RECIST 1.1
  • Prior treatment with an EGFR TKI; in Phase 2, prior treatment with a T790M-directed EGFR TKI for patients in Group B. Previous chemotherapy is allowed; in Phase 2, immediate prior therapy must be EGFR TKI
  • Patient willingness to undergo tumor biopsy at baseline and on treatment (optional for Phase 1; mandatory for Phase 2)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1; life expectancy at least 3 months
  • Adequate hematological and biological function; LVEF ≥50%

Who cannot join

  • Documented evidence in tumor of exon 20 insertion, small cell transformation, or MET amplification
  • Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroids within 2 weeks)
  • Known preexisting interstitial lung disease or pneumonitis
  • Concurrent use of QT-prolonging medication
  • Uncontrolled diabetes (HA1C > 10%) despite optional therapy
  • Cardiac abnormalities:
Show all 15Show fewer
  • Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) >450 ms
  • Inability to measure QT interval on ECG
  • Personal or family history of long QT syndrome
  • Implantable pacemaker or implantable cardioverter defibrillator
  • Resting bradycardia < 55 beats/min
  • Inability to swallow oral study treatment or any gastrointestinal disease or condition that would preclude adequate absorption of study treatment
  • Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse; uncontrolled intercurrent illness including active infection; arterial thrombosis; unstable respiratory, hepatic, renal or cardiac disease; and other active malignancy)
  • Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 16 weeks after the last dose of study treatment
  • Any contraindication, allergy, or hypersensitivity to rociletinib, trametinib, or excipients

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Tennessee Oncology, PLLC - The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1/2 Study of the Safety and Efficacy of Rociletinib When Administered in Combination With Trametinib in Patients With Activating EGFR Mutation-positive Advanced or Metastatic Non-small Lung Cancer (NSCLC)

The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib when administered in combination with trametinib.

Read the detailed description

This is a Phase 1/2, open-label, non randomized, multicenter study evaluating the safety and efficacy of rociletinib administered in combination with trametinib.

This study will be conducted in 2 phases:

Phase 1: This will be the dose escalation phase of the study. Phase 1 will determine the MAD or MTD and RP2D of the combination of rociletinib and trametinib, and evaluate its safety and tolerability and PK profile in EGFRm NSCLC patients who have failed at least one prior EGFR TKI.

Phase 2: This will be the dose expansion phase. Phase 2 will evaluate the preliminary efficacy and pharmacodynamics of the combination of rociletinib and trametinib at the RP2D in two subsets of EGFRm NSCLC patients.

Being tested
Rociletinib, Trametinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • RociletinibDrug

    Also called CO-1686

  • TrametinibDrug

    Also called Mekinist

Study groups in NCT02580708
Study groupRoleWhat they receive
Rociletinib and TrametinibExperimentalNot described
Receives: Drug: Rociletinib; Drug: Trametinib

What is being measured

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

  1. Incidence of treatment-emergent adverse events

    Treatment emergent adverse events (AEs), laboratory abnormalities and ECG abnormalities in EGFR-mutant NSCLC patients given oral rociletinib in combination with oral trametinib; defining in Phase 1 the recommended combination dose for further evaluation in Phase 2

    Measured: Continuously, up to approximately 24 months

  2. Objective Response Rate (ORR)

    ORR according to RECIST Version 1.1 as determined by Investigator assessment

    Measured: Every 6 weeks until disease progression, up to approximately 24 months

  3. Cmax of rociletinib and trametinib at steady state

    Measured: Cycle 2 Day 1 to Day 2

  4. Tmax of rociletinib and trametinib at steady state

    Measured: Cycle 2 Day 1 to Day 2

  5. AUC of rociletinib and trametinib at steady state

    Measured: Cycle 2 Day 1 to Day 2

  6. Cmin of rociletinib and trametinib at steady state

    Measured: Cycle 2 Day 1 to Day 2

  7. t1/2 of rociletinib at steady state

    Measured: Cycle 2 Day 1 to Day 2

Secondary outcomes (9)

  1. Duration of Response (DR) According to RECIST Version 1.1

    DR according to RECIST Version 1.1 as determined by Investigator assessment

    Measured: Every 6 weeks until disease progression, up to approximately 24 months

  2. Disease Control Rate (DCR) According to RECIST Version 1.1

    DCR according to RECIST Version 1.1 as determined by Investigator assessment

    Measured: Every 6 weeks until disease progression, up to approximately 24 months

  3. Progression Free Survival (PFS) According to RECIST Version 1.1

    PFS according to RECIST Version 1.1 as determined by Investigator assessment

    Measured: Every 6 weeks until disease progression, up to approximately 24 months

  4. Overall Survival (OS)

    Measured: Every 12 weeks until date of death, up to approximately 60 months

  5. Longitudinal changes in blood based biomarkers (i.e. mutations in EGFR) in ctDNA

    Measured: Biomarker samples will be collected from each subject approximately every 3 weeks, up to approximately 24 months

  6. Cmax of rociletinib metabolites at steady state

    Measured: Cycle 2 Day 1 to Day 2

  7. Tmax of rociletinib metabolites at steady state

    Measured: Cycle 2 Day 1 to Day 2

  8. AUC of rociletinib metabolites at steady state

    Measured: Cycle 2 Day 1 to Day 2

  9. Cmin of rociletinib metabolites at steady state

    Measured: Cycle 2 Day 1 to Day 2

Timeline

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

  1. First posted20 Oct 2015 (estimated)
  2. Study start30 Sep 2015
  3. Primary completion5 May 2016
  4. Study completion27 Jun 2016

Why it stopped: Discontinued development of rociletinib in NSCLC. Stopped enrollment of new patients into all studies involving rociletinib.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02580708
Sponsor's protocol ID
CO-1686-033
Status last verified
Sep 2018
First submitted
12 Oct 2015
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rociletinib and Trametinib in people with Non-small Cell Lung Cancer, run by Clovis Oncology, Inc. at 4 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 6 inclusion and 15 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (reason given: Discontinued development of rociletinib in NSCLC. Stopped enrollment of new patients into all studies involving rociletinib.). 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 treatment-emergent adverse events (time frame: Continuously, up to approximately 24 months). The study lists 7 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 NCT02580708.

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 2 Oct 2018.

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