Trial record 1 of 1 for:    01871805
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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01871805
First received: May 28, 2013
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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:
  • 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 ]
  • 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 ]

Enrollment: 115
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
Other Name: CH5424802
Experimental: Phase II: RP2 dose Drug: RO5424802
Recommended Phase II dose (600 mg) given orally twice daily
Other Name: CH5424802

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871805

  Show 41 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01871805     History of Changes
Other Study ID Numbers: NP28761
Study First Received: May 28, 2013
Last Updated: August 26, 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
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014