A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.

NCT00493155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Conditions

  • Neoplasms

Interventions

DRUG

RG1530

Administered po at escalating doses (10 cohorts)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

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
2005-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00493155 on ClinicalTrials.gov