Skip to main content
OpenTrials
Completed

NCT Number: NCT00532090

A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, >=18 years of age;
  • advanced and/or metastatic solid tumor malignancy;
  • measurable or evaluable disease;
  • ECOG performance status 0 or 1.

Exclusion criteria

  • prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
  • prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
  • major surgery within 28 days of first receipt of study drug.

Treatment and study plan

RG4733

Drug

Administered orally daily at ascending doses to successive cohorts of patients

Other names: RO4929097

Primary outcomes

  1. AEs, laboratory parameters.

    Time frame: Throughout study

Secondary outcomes

  1. Tumor assessments

    Time frame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter

  2. Pharmacokinetic profile

    Time frame: After first dose and last dose (or day 15) of cycles 1 and 2

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 19, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.