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A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00400361
First received: November 15, 2006
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

November 15, 2006
July 19, 2011
April 2006
April 2011   (final data collection date for primary outcome measure)
AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety: Adverse events, laboratory tests. Pharmacokinetics: Cmax, Tmax, AUC, clearance, Vdss terminal elimination half-life.
Complete list of historical versions of study NCT00400361 on ClinicalTrials.gov Archive Site
Tumor response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Efficacy: Tumor response.
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics 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 individuals.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: RG1507
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
Experimental: 1
Intervention: Drug: RG1507
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
  • metastatic or locally advanced disease, not curable by any currently available treatment.

Exclusion Criteria:

  • severe, uncontrolled systemic disease;
  • patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
  • patients with diabetes mellitus.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00400361
BO19373
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2011

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