Back to resultsAn Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)
Primary Purpose
Neoplasms Malignant
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Crizotinib
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms Malignant focused on measuring neoplasm malignant, lymphoma, neuroblastoma, Crizotinib, anaplastic lymphoma kinase, ALK
Eligibility Criteria
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
Sites / Locations
- Highlands Oncology Group
- Highlands Oncology Group
- Highland Oncology Group
- Washington University School of Medicine
- Comprehensive Cancer Centers of Nevada
- OHSU Center for Health and Healing 2
- Oregon Health & Science University
- Oregon Health and Science University
- Greenville Health System, Institute for Translational Oncology Research
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- SUN Yat-Sen University Cancer Center
- Centro di Ricerca di Fase 1 ASST-Monza
- PO San Gerardo, ASST Monza-U.O Ematologia
- National Hospital Organization Nagoya Medical Center
- National Cancer Center Hospital
- National Hospital Organization Kyushu Cancer Center
- Seoul National University Hospital
- Samsung Medical Center
- GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health
- Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva
- National Taiwan University Hospital, Department of Internal Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crizotinib
Arm Description
Outcomes
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
Overall Response Rate
Secondary Outcome Measures
Duration of Response
Plasma concentrations of crizotinib
Overall Survival
Proportion of patients with each of the ALK genetic events
Progression-Free Survival (PFS)
Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01121588
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2011 (Actual)
Primary Completion Date
September 7, 2023 (Anticipated)
Study Completion Date
September 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms Malignant
Keywords
neoplasm malignant, lymphoma, neuroblastoma, Crizotinib, anaplastic lymphoma kinase, ALK
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crizotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Other Intervention Name(s)
PF-02341066
Intervention Description
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Primary Outcome Measure Information:
Title
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
Time Frame
36 Months
Title
Overall Response Rate
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Duration of Response
Time Frame
36 months
Title
Plasma concentrations of crizotinib
Time Frame
30 Months
Title
Overall Survival
Time Frame
36 Months
Title
Proportion of patients with each of the ALK genetic events
Time Frame
36 Months
Title
Progression-Free Survival (PFS)
Time Frame
36 Months
Title
Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Highland Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
OHSU Center for Health and Healing 2
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Greenville Health System, Institute for Translational Oncology Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Chaoyang District
ZIP/Postal Code
100021
Country
China
Facility Name
SUN Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Centro di Ricerca di Fase 1 ASST-Monza
City
Monza
ZIP/Postal Code
20090
Country
Italy
Facility Name
PO San Gerardo, ASST Monza-U.O Ematologia
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva
City
Saint-Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
National Taiwan University Hospital, Department of Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081013&StudyName=An%20Investigational%20Drug%2C%20Crizotinib%20%28PF-02341066%29%2C%20Is%20Being%20Studied%20In%20Tumors%2C%20Except%20Non-Small%20Cell%20Lung%20Cancer%2C%20That%20Are%20Posit
Description
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Learn more about this trial
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)
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