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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

NCT00613691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-10-21

No results posted yet for this study

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.

Conditions

  • Carcinoma

Interventions

DRUG

SPI-1620

SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Anthony Tolcher, MD · START

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-01-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00613691 on ClinicalTrials.gov