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Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors

Phase 1
20 Years
74 Years
Not Enrolling

Thank you

Trial Information

Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors

Inclusion Criteria:

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

2. Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding

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

4. Adequate hepatic, renal, and bone marrow function

5. Age 20 to 74 years

6. Willingness of male and female subjects, who are not surgically sterile or
postmenopausal, to use reliable methods of birth control for the duration of the
study and for 6 months and 30 days after the last dose of test article for male and
female, respectively

7. Life expectancy of at least 12 weeks

Exclusion Criteria:

1. Use of any systemic antitumor agents or any investigational agent within 28 days
before the enrollment (42 days if the previous chemotherapy included nitrosoureas or
mitomycin C)

2. Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4

3. Prior exposure to SKI-606 or any other Src-kinase inhibitor

4. Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from
previous surgery should be complete before day 1)

5. Subjects unable or unwilling to swallow SKI-606 capsules

6. Active central nervous system (CNS) metastases, as indicated by clinical symptoms,
cerebral edema, requirement for corticosteroids and/or progressive growth

7. Recent or ongoing clinically-significant gastrointestinal disorder

8. Pregnant or breastfeeding women

9. Subjects who meet the following criteria:

- Evidence of serious active infection, significant medical or psychiatric illness

- History of unexplained syncope or known ventricular arrythmia

- Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis
hepatitis C

- Hypokalemia

- Unstable concurrent medical conditions

- Any other condition that, in the investigator's judgment, make the subject
inappropriate for this study the subject inappropriate for this study

Type of Study:


Study Design:

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

Outcome Measure:

Safety as measured by AE information. Tolerability as measured by DLT observation.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

February 2006

Completion Date:

December 2008

Related Keywords:

  • Tumors
  • PHASE 1 SKI-606 Solid tumor