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Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose-limiting Toxicities (DLT) in Part 1

Outcome Description:

DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.

Outcome Time Frame:

Part 1 Baseline up to Day 28

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A1-100

NCT ID:

NCT00195260

Start Date:

October 2004

Completion Date:

November 2007

Related Keywords:

  • Neoplasms
  • Solid tumors
  • Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteAsheville, North Carolina  28801