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Safety of SGI-1776, A PIM Kinase Inhibitor in Refractory Prostate Cancer and Relapsed/Refractory Non Hodgkin's Lymphoma

NCT00848601 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-08-02

No results posted yet for this study

Summary

Patients with hormone and docetaxel refractory prostate cancer or relapsed/refractory non-Hodgkin's lymphoma for which no available standard therapy or therapy which may provide clinical benefit is available will be enrolled. Primary objectives: estimate the maximum tolerated dose and dose-limiting toxicities. Secondary objectives: Response rate, pharmacokinetic and pharmacodynamic profiles, Prostate Specific Antigen response and renal elimination.

Conditions

Interventions

DRUG

SGI-1776

Starting dose 100 mg (total daily dose) administer as 50 mg every 12 hours for 14 days of a 21-day cycle, dose escalation in successive cohorts until progression or toxicity develops

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT00848601 on ClinicalTrials.gov