A Phase 1 Study of S-3304 in Patients With Solid Tumors

Sponsor

Shionogi (Industry)

Overall Status

Completed

CT.gov ID

NCT00033215

Collaborator

(none)

Enrollment

Locations

16.3

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: S-3304	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of S-3304 in Patients With Solid Tumors

Actual Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Feb 13, 2003

Actual Study Completion Date :

Mar 12, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)
Must be able to tolerate oral medication Exclusion criteria
Patients with other serious illnesses
Patients who are receiving treatments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Denver	Colorado	United States	80262
2	H. Lee Moffitt Concer Center and Research Institute	Tampa	Florida	United States	33612
3	Roswell Park Cancer Center	Buffalo	New York	United States	14263
4	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195