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TerminatedPhase 1 / Phase 2NCT02580708
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRociletinib and Trametinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 2, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Clovis Oncology, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Clovis Oncology, Inc.
Interventions being studied
Drug: Rociletinib; Drug: Trametinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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%
Reasons someone may not be able to joinExclusion criteria
  • 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:
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Washington University School of MedicineSt Louis, Missouri
  • Levine Cancer InstituteCharlotte, North Carolina
  • Tennessee Oncology, PLLC - The Sarah Cannon Research InstituteNashville, Tennessee
  • Virginia Cancer SpecialistsFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 2, 2018. Always confirm current availability with the study team.

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