SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT01748019

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors

ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.

NCT01748019 Solid Tumors

1 Interventions

Name: ST1968

Description: ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks

Type: Drug


Primary Outcomes

Description: 2/6 patients with a Dose Limiting Toxicity (DLT) at the first cycle (21 days)

Measure: Maximum Tolerated Dose (MTD) of ST1968 given I.V. once every week for 2 consecutive weeks every 3 weeks and MTD of ST1968 given I.V. once every 3 weeks

Time: 21 days

Secondary Outcomes

Description: safety assessments (routine physical examinations and laboratory evaluations) and severity of adverse events based on the NCI-Common Terminology Criteria for Adverse Events V. 3.0 (NCI-CTCAE)

Measure: Adverse events, physical examination and laboratory tests (hematology and biochemistry) as a measure of safety and tolerability

Time: 21 days of each cycle of therapy

Description: objective tumor response based on RECIST criteria

Measure: Tumor response

Time: 4 weeks

Description: full blood and urine PK

Measure: Tmax, Cmax, AUC0-24, AUC-last, T1/2,CL

Time: 21 days

Purpose: Treatment

Single Group Assignment

There is one SNP


1 Q21D

A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days (D1, D8 Q21D schedule), over 2 h. --- Q21D ---

Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule. --- Q21D ---

Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule. --- Q21D --- --- Q21D ---

HPO Nodes