Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

NCT00195260

Last updated date
Study Location
Pfizer Investigational Site
Birmington, Alabama, 35233, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

- Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

- Other inclusion applies.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Use of any systemic antitumor agents or any investigational agent within 28 days
before the first dose of test article is administered.


- Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or
radiotherapy within 14 days before the first dose of test article (recovery from
previous surgery should be complete before day 1).


- Active central nervous system (CNS) metastases, as indicated by clinical symptoms,
cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS
metastases must be stable for >= 2 weeks before day 1).


- Other exclusion applies.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Official Title  ICMJE Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors
Brief Summary To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: bosutinib
    Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.
  • Drug: bosutinib
    400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Study Arms  ICMJE
  • Experimental: Dose escalation
    Dose finding study of monotherapy bosutinib in patients with advanced solid tumors.
    Intervention: Drug: bosutinib
  • Experimental: Colorectal Cancer
    Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
    Intervention: Drug: bosutinib
  • Experimental: Pancreatic Cancer
    Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
    Intervention: Drug: bosutinib
  • Experimental: Non-Small Cell Lung Cancer (NSCLC)
    Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
    Intervention: Drug: bosutinib
Publications * Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10. Retraction in: Drug Metab Pharmacokinet. 2019 Apr;34(2):163.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2012)
151
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
150
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Other inclusion applies.

Exclusion Criteria:

  • Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.
  • Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
  • Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for >= 2 weeks before day 1).
  • Other exclusion applies.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195260
Other Study ID Numbers  ICMJE 3160A1-100
B1871012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP