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Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients

NCT01526928 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2020-08-04

Study results available
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Summary

Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.

Conditions

  • Locally Advanced or Metastatic Non Small Cell Lung Cancer

Interventions

DRUG

Rociletinib

Phase 1: Rociletinib \<900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles

DRUG

Rociletinib

Phase 1: Rociletinib 900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles

DRUG

Rociletinib

Phase 1: Rociletinib 500 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles Phase 2: Rociletinib 500 mg BID HBr will be administered daily

DRUG

Rociletinib

Phase 1: Rociletinib 625 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles Phase 2: Rociletinib 625 mg BID HBr will be administered daily

DRUG

Rociletinib

Phase 1: Rociletinib 750 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles Phase 2: Rociletinib 750 mg BID HBr will be administered daily

DRUG

Rociletinib

Phase 1: Rociletinib 1000 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles Phase 2: Rociletinib 1000 mg BID HBr will be administered daily

Sponsors & Collaborators

  • Clovis Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-27
Primary Completion
2018-07-03
Completion
2018-08-27

Countries

  • United States
  • Australia
  • France
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526928 on ClinicalTrials.gov