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Adult Trials: 18+ Years
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 alopecia)
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
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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating SKI-606 in Subject With Solid Tumors | |||
| Official Title ICMJE | Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors | |||
| Brief Summary | The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors | |||
| 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 | Tumors | |||
| Intervention ICMJE | Drug: SKI-606 | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Drug: SKI-606 | |||
| Publications * | Not Provided | |||
* 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 | 28 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | December 2008 | |||
| Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 20 Years to 74 Years (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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01001936 | |||
| Other Study ID Numbers ICMJE | 3160A1-102 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||