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)

Neoplasms Malignant Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01121588
• Other study ID #: A8081013
• Secondary ID: PROFILE 10132010
• Status: Terminated
• Phase: Phase 1
• Start date: March 22, 2011
• Est. completion date: September 7, 2023

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Neoplasms
• Neoplasms Malignant

Intervention

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

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Chaoyang District
China	SUN Yat-Sen University Cancer Center	Guangzhou	Guangdong
Italy	Centro di Ricerca di Fase 1 ASST-Monza	Monza
Italy	PO San Gerardo, ASST Monza-U.O Ematologia	Monza
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Russian Federation	GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health	Saint-Petersburg
Russian Federation	Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva	Saint-Petersburg
Taiwan	National Taiwan University Hospital, Department of Internal Medicine	Taipei
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Greenville Health System, Institute for Translational Oncology Research	Greenville	South Carolina
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	OHSU Center for Health and Healing 2	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Highlands Oncology Group	Rogers	Arkansas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Highland Oncology Group	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  China,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall Response Rate		36 months
Secondary	Duration of Response		36 months
Secondary	Plasma concentrations of crizotinib		30 Months
Secondary	Overall Survival		36 Months
Secondary	Proportion of patients with each of the ALK genetic events		36 Months
Secondary	Progression-Free Survival (PFS)		36 Months
Secondary	Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available		36 months

External Links

•   To obtain contact information for a study center near you, click here.