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
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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 | |||||