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Open Label Phase I Study of P276-00 in Patients With Advanced Refractory Neoplasms

NCT00407498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-01-01

No results posted yet for this study

Summary

P276-00 is specific Cdk4-D1 and Cdk1-B inhibitor. P276-00 exhibited significant tumour reduction in animal models with less adverse effects.Based on the results from various in-vitro studies, P276-00 could be a potential candidate as a new mechanism based drug for the treatment of cancer.This Phase I study will determine the Maximum Tolerated Dose,Dose Limiting Toxicity and efficacy of P 276-00 in patients with advanced Refractory neoplasms.

Conditions

Interventions

DRUG

P276-00

Starting dose of 9 mg/m2/day from day 1to 5 and day 8 to 12 in 21 day cycle.Protocol wa amended to dose the subjects for day 1 to5 in 21 day cycle after 34.4 mg/m2/day cohort.Maximum dose administered was 259 mg/m2/day

Sponsors & Collaborators

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Hal Hirte, MD, FRCP · Juravinsky Cancer Centre

  • Tara Baetz, MD, FRCP · Kingston Health Sciences Centre

  • Raghunadharao D, MD, DM · Nizam's Institute of Medicai Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-03-31
Completion
2008-09-30

Countries

  • Canada
  • India

Study Locations

More Related Trials

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 NCT00407498 on ClinicalTrials.gov