Clinical trial NCT01121588: Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms Malignant
Keywords: neoplasm malignant
lymphoma
neuroblastoma
Crizotinib
anaplastic lymphoma kinase
ALK
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 44
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)
measure: Number of Participants With All-Causality TEAEs in the Pediatric Population
timeFrame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)
measure: Number of Participants With Treatment-Related TEAEs
timeFrame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)
measure: Number of Participants With Treatment-Related TEAEs in the Pediatric Population
timeFrame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)
measure: Number of Participants With Laboratory Test Results Shifted From Grade <=2 At Baseline to Grade 3 or 4 Postbaseline (Hematology and Chemistries)
timeFrame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)
measure: 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
timeFrame: From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)
measure: Objective Response Rate (ORR) - Percentage of Participants With Objective Response
timeFrame: 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:
measure: Progression-Free Survival (PFS) Based on Investigator Assessement
timeFrame: 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)
measure: Duration of Response (DR) Based on Investigator Assessement
timeFrame: 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)
measure: Percentage of Participants Surviving at 6 Months and 1 Year
timeFrame: At 6 months and 1 year after first dose
measure: Overall Survival (OS)
timeFrame: From the first dose of study treatment to the date of death due to any cause (maximum 444 weeks)
measure: Steady-State Pre-dose Concentration (Ctrough) for Crizotinib on Day 1 of Cycles 2, 3 and 5
timeFrame: Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5
measure: Steady-State Ctrough for PF-06260182 on Day 1 of Cycles 2, 3 and 5
timeFrame: Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5
measure: Ctrough Ratios of PF-06260182 to Crizotinib on Day 1 of Cycles 2, 3 and 5
timeFrame: Predose within -1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5
measure: Number of Participants With ALK Genetic Events
timeFrame: From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years)
measure: Phosphorylation Status of ALK in the Tumor Samples From Surgery or Biopsy Pre and Post Treatment
timeFrame: From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years)
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Springdale
country: United States
facility: Highland Oncology Group
state: Arkansas
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Portland
country: United States
facility: OHSU Center for Health and Healing 2
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System, Institute for Translational Oncology Research
state: South Carolina
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Chaoyang District
city: Guangzhou
country: China
facility: SUN Yat-Sen University Cancer Center
state: Guangdong
city: Monza
country: Italy
facility: Centro di Ricerca di Fase 1 ASST-Monza
city: Monza
country: Italy
facility: PO San Gerardo, ASST Monza-U.O Ematologia
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Saint-Petersburg
country: Russian Federation
facility: GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health
city: Saint-Petersburg
country: Russian Federation
facility: Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Department of Internal Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: