Trial record 1 of 1 for:    NCT01871805
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A Study of CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 28, 2013
Last updated: August 19, 2014
Last verified: August 2014

This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of CH5424802/RO5424802 in patients with ALK-rearranged non-small cell l ung cancer who failed crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of CH5424802/RO5424802 orally twice daily. In Phase II

, patients who failed crizotinib treatment will receive the recommended phase II dose (600 mg) daily in two oral doses.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: RO5424802
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Phase I: Dose-limiting toxicity [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: Yes ]
  • Phase II: Objective response rate (ORR) evaluated by an independent review committee (IRC) using RECIST v. 1.1 criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: EORTC QLQ-C30/QLQ-LC13 questionnaires [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: CNS progression rate (CPR) evaluated by IRC according to RECIST v. 1.1 and RANO criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics (Phase I): Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and post-dose up to Day 15 Cycle 1, pre- and post-dose Cycles 2 and 4 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (Phase II): Trough concentrations (Ctrough) [ Time Frame: Pre- and post-dose Day 1 of Cycles 1, 2 and 4 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase I: Tumor response [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: ORR evaluated by investigator assessment using RECIST v. 1.1 criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: Disease control rate evaluated by IRC and investigator assessment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: Progression-free survival evaluated by IRC and investigator assessment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: Overall survival [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: Duration of response evaluated by IRC and investigator assessment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: CNS objective response rate (CORR) evaluated by IRC according to RECIST v. 1.1 and RANO criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Phase II: CNS duration of response (CDOR) evaluated by IRC according to RECIST v. 1.1 and RANO criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: April 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I: dose-escalation Drug: RO5424802
multiple escalating doses given orally twice daily
Experimental: Phase II: RP2 dose Drug: RO5424802
Recommended Phase II dose (600 mg) given orally twice daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic non-small cell lung cancer (NSCLC)
  • ALK-rearrangement confirmed by FDA approved test
  • NSCLC that has failed crizotinib treatment
  • Measurable disease as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  • Adequate hematologic, hepatic and renal function

Exclusion Criteria:

  • Prior therapy with ALK inhibitor other than crizotinib
  • Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
  • History of serious cardiac dysfunction
  • History of or current active infection with hepatitis B, hepatitis C or HIV
  • Clinically significant gastrointestinal abnormality that would affect absorption of the drug
  • Pregnant or lactating women
  Contacts and Locations
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Please refer to this study by its identifier: NCT01871805

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01871805     History of Changes
Other Study ID Numbers: NP28761
Study First Received: May 28, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on August 21, 2014