Spots Global Cancer Trial Database for KRN5500 in Treating Patients With Solid Tumors

Study Description

Brief Summary: Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid tumors. Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer cells from dividing so they stop growing or die

Detailed Description: PRIMARY OBJECTIVES: I. To establish the MTD and identify the DLTs of the investigational agent KRN5500 when administered by a 72-hr continuous i.v. infusion to patients with solid tumors who have failed standard therapy or for whom no standard therapy exists. II. To establish and assess the safety of an appropriate dose for phase II studies. III. To characterize the pharmacokinetics of KRN5500 in patients when administered by a 72 hr continuous IV infusion. IV. To characterize the response to KRN5500 by FLT-PET scanning at the MTD. SECONDARY OBJECTIVES: I. To describe any preliminary evidence of antitumor activity. II. Establish pharmacodynamic relationships for the pharmacological effect of the drug upon surrogate markers of activity and host toxicity. III. To compare the toxicity profiles for the 1 hr i.v. infusion and 72 hr continuous i.v. infusion administration schedules. OUTLINE: This is a dose-escalation, multicenter study. Patients receive KRN5500 IV over 24-72 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations. After the longest duration of infusion time is safely reached, cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose. Patients are followed every 4 weeks until resolution of all toxicity. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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