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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493155
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

June 27, 2007
June 28, 2007
November 2, 2016
October 2005
February 2009   (Final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: Throughout study ]
Maximum tolerated dose.
Complete list of historical versions of study NCT00493155 on Archive Site
  • AEs, laboratory parameters [ Time Frame: Throughout study ]
  • Plasma levels of R1530 [ Time Frame: Throughout study ]
  • Tumor assessments [ Time Frame: Every 2 cycles of treatment ]
Safety: AEs, laboratory parameters. Efficacy: Tumor assessments every 2 cycles of treatment. Pharmacokinetics: plasma levels of R1530; effect of food on pharmacokinetic parameters.
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A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.
"An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."
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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: RG1530
Administered po at escalating doses (10 cohorts)
Experimental: 1
Intervention: Drug: RG1530
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • cancer not amenable to curative treatment (ie advanced and/or metastatic);
  • measurable or evaluable disease;
  • adequate cardiac, hepatic and renal function.

Exclusion Criteria:

  • patients with known CNS metastases;
  • serious cardiovascular illness or other medical conditions;
  • prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment;
  • inability to swallow oral medications, or impaired gastrointestinal absorption.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP