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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00033215

Enrollment

Registered

2002-04-10

Start date

2001-11-30

Completion date

2003-03-12

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

neovascularization, matrix metalloproteinases, antiangiogenesis, type IV collagenases

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

Interventions

DRUGS-3304

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026