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)
NCT01121588
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms Malignant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
15 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Neoplasms MalignantAn Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)
NCT01121588
- Fayetteville, Arkansas
- Rogers, Arkansas
- Springdale, Arkansas
- Creve Coeur, Missouri
- Saint Louis, Missouri
- Las Vegas, Nevada
- Portland, Oregon
- Portland, Oregon
- Portland, Oregon
- Greenville, South Carolina
- Beijing, Chaoyang District
- Guangzhou, Guangdong
- Monza,
- Monza,
- Nagoya, Aichi
- Chuo-ku, Tokyo
- Fukuoka,
- Seoul,
- Seoul,
- Saint-Petersburg,
- Saint-Petersburg,
- Taipei,
ALL GENDERS
15 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | 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 ICMJE | 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 | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||
| Condition ICMJE | Neoplasms Malignant | ||||
| Intervention ICMJE | Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule Other Name: PF-02341066 | ||||
| Study Arms ICMJE | Experimental: Crizotinib
Intervention: Drug: Crizotinib | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE | 44 | ||||
| Original Estimated Enrollment ICMJE | 40 | ||||
| Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 15 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China, Italy, Japan, Korea, Republic of, Russian Federation, Taiwan, United States | ||||
| Removed Location Countries | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01121588 | ||||
| Other Study ID Numbers ICMJE | A8081013 PROFILE 1013 2010-022978-14 ( EudraCT Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||