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Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma

NCT00486135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2013-02-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.

Conditions

Interventions

DRUG

XL147 (SAR245408)

Gelatin capsules supplied in 25-mg and 100-mg dosage strengths

DRUG

XL147 (SAR245408)

Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

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
2007-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT00486135 on ClinicalTrials.gov