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
Stopped early · Phase 1/Phase 2
Conditions studied: Non-small Cell Lung Cancer
In brief
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib when administered in combination with trametinib.
Key facts
- Study ID
- NCT02580708
- Run by
- Clovis Oncology, Inc.
- People needed
- 7
- Starts
- 2015-09-30
- Expected to finish
- 2016-06-27
- Last updated by the study team
- 2018-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Tennessee Oncology, PLLC - The Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Virginia Cancer Specialists — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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