A Multiple Ascending Dose Study of R1507 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: NCT00400361
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

November 15, 2006
November 16, 2006
November 2, 2016
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 ]
Safety: Adverse events, laboratory tests. Pharmacokinetics: Cmax, Tmax, AUC, clearance, Vdss terminal elimination half-life.
Complete list of historical versions of study NCT00400361 on Archive Site
Tumor response [ Time Frame: Event driven ]
Efficacy: Tumor response.
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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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
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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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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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