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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00493155
First received: June 27, 2007
Last updated: August 4, 2014
Last verified: August 2014

June 27, 2007
August 4, 2014
October 2005
February 2009   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Maximum tolerated dose.
Complete list of historical versions of study NCT00493155 on ClinicalTrials.gov Archive Site
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Plasma levels of R1530 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Tumor assessments [ Time Frame: Every 2 cycles of treatment ] [ Designated as safety issue: No ]
Safety: AEs, laboratory parameters. Efficacy: Tumor assessments every 2 cycles of treatment. Pharmacokinetics: plasma levels of R1530; effect of food on pharmacokinetic parameters.
Not Provided
Not Provided
 
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, tol erability and pharmacokinetics of R1530 administered orally to patients with adv anced or metastatic solid tumors. R1530 will be administered daily for 14 days a t the starting dose; this dose will be escalated in subsequent cohorts of patien ts, after a satisfactory assessment of safety and tolerability of the previous d ose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 indiv iduals.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: RG1530
Administered po at escalating doses (10 cohorts)
Experimental: 1
Intervention: Drug: RG1530
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00493155
NO18674
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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