Phase 1 N=51 Treatment

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

Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00195260 ↗

Enrolled (actual)

Serious AEs

50.3%

Results posted

Feb 2013

Primary outcome: Primary: Number of Participants With Dose-limiting Toxicities (DLT) in Part 1 — 0; 0; 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: bosutinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Dose-limiting Toxicities (DLT) in Part 1	0; 0; 1; 1; 0; 1	—
PRIMARY Number of Participants With Adverse Events (AEs) by Seriousness	4; 4; 6; 7; 7; 7	—
PRIMARY Duration of Most Frequently Observed Adverse Events (AEs)	1.0; NA; 12.0; 2.0; 3.5; 7.0	—
PRIMARY Number of Participants With Best Overall Response (BOR) in Part 1	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Best Overall Response (BOR) in Part 2	0; 0; 0; 0; 0; 0	—
PRIMARY Maximum Tolerated Dose (MTD) in Part 1	500	—
SECONDARY Maximum Tolerated Dose (MTD) for Prolonged Use	400	—
SECONDARY Number of Participants With Change From Baseline in Laboratory Test Results	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray	0; 0; 0; 0; 0; 0	—
SECONDARY Concomitant Medications Used for Management of Adverse Events (AEs)	—	—
SECONDARY Change From Baseline in Karnofsky Performance Score	—	—
SECONDARY Number of Participants With Change From Baseline in Physical Examination	0; 0; 2; 2; 0; 0	—
SECONDARY Number of Participants With Change From Baseline in Opthalmologic Examination	0; 0; 0; 1; 0; 0	—
SECONDARY Overall Survival (OS) in Part 2	27.7; 14.7; 34.0	—
SECONDARY Progression Free Survival (PFS) in Part 2	6.0; 6.0; 5.7	—
SECONDARY Maximum Observed Plasma Concentration (Cmax)	4.89; 17.0; 43.1; 63.7; 117.0; 125.0	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax)	6.01; 4.08; 6.00; 6.00; 4.00; 4.00	—
SECONDARY Plasma Decay Half-Life (t1/2)	12.86; 18.61; 20.80; 17.12; 18.63; 21.87	—
SECONDARY Area Under the Concentration-Time Curve (AUC)	129.0; 284.0; 920.0; 1200.0; 2340.0; 2950.0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00195260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.