An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Sponsor

Pfizer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01121588

Collaborator

(none)

Enrollment

Locations

Arm

141.3

Anticipated Duration (Months)

2.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Malignant	Drug: Crizotinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PHASE 1B OPEN-LABEL STUDY OF THE SAFETY AND CLINICAL ACTIVITY OF CRIZOTINIB (PF-02341066) IN TUMORS WITH GENETIC EVENTS INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK ) GENE LOCUS

Actual Study Start Date :

Mar 22, 2011

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crizotinib	Drug: Crizotinib Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule Other Names: PF-02341066

Arm

Intervention/Treatment

Experimental: Crizotinib

Drug: Crizotinib

Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule

Other Names:

PF-02341066

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [36 Months]
Overall Response Rate [36 months]

Secondary Outcome Measures

Duration of Response [36 months]
Plasma concentrations of crizotinib [30 Months]
Overall Survival [36 Months]
Proportion of patients with each of the ALK genetic events [36 Months]
Progression-Free Survival (PFS) [36 Months]
Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

histologically or cytologically proven diagnosis of malignancy other than NSCLC
positive for translocation or inversion event involving the ALK gene locus
positive for ALK amplification events
positive for ALK activating point mutations

Exclusion Criteria:

mutations of amplifications involving the c-Met gene but not the ALK gene
concurrent treatment on another therapeutic clinical trial
prior therapy specifically directed against ALK

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Highlands Oncology Group	Fayetteville	Arkansas	United States	72703
2	Highlands Oncology Group	Rogers	Arkansas	United States	72758
3	Highland Oncology Group	Springdale	Arkansas	United States	72762
4	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
5	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
6	OHSU Center for Health and Healing 2	Portland	Oregon	United States	97239
7	Oregon Health & Science University	Portland	Oregon	United States	97239
8	Oregon Health and Science University	Portland	Oregon	United States	97239
9	Greenville Health System, Institute for Translational Oncology Research	Greenville	South Carolina	United States	29605
10	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Chaoyang District	China	100021
11	SUN Yat-Sen University Cancer Center	Guangzhou	Guangdong	China	510060
12	Centro di Ricerca di Fase 1 ASST-Monza	Monza		Italy	20090
13	PO San Gerardo, ASST Monza-U.O Ematologia	Monza		Italy	20900
14	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi	Japan	460-0001
15	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
16	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
17	Seoul National University Hospital	Seoul		Korea, Republic of	03080
18	Samsung Medical Center	Seoul		Korea, Republic of	06351
19	GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health	Saint-Petersburg		Russian Federation	197022
20	Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva	Saint-Petersburg		Russian Federation	197101
21	National Taiwan University Hospital, Department of Internal Medicine	Taipei		Taiwan	100