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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmington, Alabama, 35233 United States
Contact
1-800-718-1021
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.

NCT00195260
Pfizer
Completed
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

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Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
  • 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.
  • 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
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
November 2007
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00195260
3160A1-100
B1871012
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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