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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Locally advanced or metastatic non-small cell lung cancer (NSCLC)

- ALK-rearrangement confirmed by FDA approved test

- Phase I: NSCLC that has failed crizotinib treatment

- Phase II: NSCLC that has failed crizotinib and at least one line of platinum-based
chemotherapy treatment

- Measurable disease as defined by RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status
- Adequate hematologic, hepatic and renal function

Exclusion Criteria:

- Prior therapy with ALK inhibitor other than crizotinib

- Brain 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Dose-limiting toxicity

Outcome Time Frame:

approximately 2.5 years

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NP28761

NCT ID:

NCT01871805

Start Date:

August 2013

Completion Date:

May 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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