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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
ALK-Rearranged 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


Inclusion Criteria:



- ECOG performance status =< 2

- Confirmed of ALK-positive NSCLC by FDA approved kit

- NSCLC that has failed crizotinib treatment for Phase I and II A

- Measurable disease defined by RECIST 1.1

- Adequate hematologic, hepatic, renal function

Exclusion Criteria:

- Prior therapy with an ALK inhibitor other than crizotinib

- Brain metastases, which are symptomatic and/or requiring treatment

- History of serious cardiac dysfunction

- Clinically significant gastrointestinal abnormality that would affect the absorption
of drug

- Pregnant or a lactating woman

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Dose limiting toxicity, Phase II: Response Rate

Outcome Time Frame:

Phase I/II: April 2012 to September 2014

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AF002JG

NCT ID:

NCT01588028

Start Date:

April 2012

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Swedish Cancer InstituteSeattle, Washington  98104
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Moffitt Cancer CenterTampa, Florida  33612
University of California Irvine Medical CenterOrange, California  92668
Karmanos Cancer CenterDetroit, Michigan  48201
Dana-Faber Cancer InstituteBoston, Massachusetts