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

NCT01121588 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: A80810132010-022978-14
• Study Type: interventional
• Target: 44
• Locations: 7 countries
• Sites: 21

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.

Conditions

Neoplasms Malignant

Keywords

neoplasm malignant; lymphoma; neuroblastoma; Crizotinib; anaplastic lymphoma kinase; ALK

Outcome Measures

Primary Outcomes (7)

• Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care activity of daily living (ADL); Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.

  From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)

• Number of Participants With All-Causality TEAEs in the Pediatric Population

  An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication.Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.

  From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)

• Number of Participants With Treatment-Related TEAEs

  Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.

  From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)

• Number of Participants With Treatment-Related TEAEs in the Pediatric Population

  Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.

  From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)

• Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries)

  Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and clinical chemistry parameters were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated.

  From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)

• Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries) in the Pediatric Population

  Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Both hematology and chemistry laboratory assessments were analyzed. Grades of severity were defined by CTCAE v4.0. Grade 1 = mild adverse event; Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Unplanned laboratory test results were also included.

  From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)

• Objective Response Rate (ORR) - Percentage of Participants With Objective Response

  Percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) as determined by the investigators. CR = disappearance of all target lesions. PR = greater than equal to (\>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. ORR based on Cheson criteria was defined similarly however, confirmation of response was not required. If participant had tumor response assessed only by RECIST or Cheson, then ORR was based on the single result. If tumor response was assessed by both RECIST and Cheson, then ORR was reported based on tumor response by Cheson criteria unless the Cheson has indeterminate result, in which case the RECIST result was reported. Participant(s) who did not have tumor assessment results from either RECIST 1.1 or Cheson criteria reported at baseline were to be excluded from the analysis.

  From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occured first (maximum 374 weeks)

Secondary Outcomes (9)

• Progression-Free Survival (PFS) Based on Investigator Assessement

  From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occurs first (maximum 444 weeks)

• Duration of Response (DR) Based on Investigator Assessement

  From the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum 374 weeks)

• Percentage of Participants Surviving at 6 Months and 1 Year

  At 6 months and 1 year after first dose

• Overall Survival (OS)

  From the first dose of study treatment to the date of death due to any cause (maximum 444 weeks)

• Steady-State Pre-dose Concentration (Ctrough) for Crizotinib on Day 1 of Cycles 2, 3 and 5

  Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5

Study Arms (1)

Crizotinib

EXPERIMENTAL

Drug: Crizotinib

Interventions

Crizotinib DRUG

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

Also known as: PF-02341066

Crizotinib

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (21)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

Highland Oncology Group

Springdale, Arkansas, 72762, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

OHSU Center for Health and Healing 2

Portland, Oregon, 97239, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Greenville Health System, Institute for Translational Oncology Research

Greenville, South Carolina, 29605, United States

Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Chaoyang District, 100021, China

Location

SUN Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Centro di Ricerca di Fase 1 ASST-Monza

Monza, 20090, Italy

Location

PO San Gerardo, ASST Monza-U.O Ematologia

Monza, 20900, Italy

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health

Saint Petersburg, 197022, Russia

Location

Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva

Saint Petersburg, 197101, Russia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

National Taiwan University Hospital, Department of Internal Medicine

Taipei, 100, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Lymphoma; Neuroblastoma

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: March 22, 2011
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); RU (2); KR (2); US (9); JP (3); TW (1); IT (2)