A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma

Carcinoma Clinical Trial

Official title: A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma

Status Completed

Clinical Trial Summary

This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I.

Clinical Trial Description

This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Eligible patients will receive SPI-1620 delivered intravenously over one minute on Days 1, 8 and 15. On Day 8 patients will undergo a series of four H215O PET Blood Flow (BF) scans which will be used to assess alterations in BF induced by SPI-1620 in tumor and non-tumor ROIs (Region of Interest). Fifteen minutes after receiving SPI-1620 on Day 15, patients will receive docetaxel, 60 mg/m2, administered by infusion over 1 hour. Accelerated dose escalation of SPI-1620 will be employed: one patient will be treated at each dose level with 100% increases between dose levels. If any grade 2 or higher, related AE occurs, the trial will revert to 3-patient cohorts with 40% dose escalation between groups. There will be no intrapatient dose escalation. Dose escalation will continue until there is either no further increase in tumor blood flow as assessed by H215O PET scan, or until significant toxicity is observed. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I. If 60 mg/m 2 was tolerated in Part I then up to six patients in Part II will receive docetaxel at a dose of 80 mg/m2 once every 3 weeks. If this is tolerated the next group of patients will receive docetaxel 100 mg/m2 once every 3 weeks. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma

• NCT number: NCT00613691
• Study type: Interventional
• Source: Spectrum Pharmaceuticals, Inc
• Status: Completed
• Phase: Phase 1
• Start date: January 2008
• Completion date: December 2012