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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 15, 2006
Last updated: May 4, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Drug: RG1507
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: April 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00400361

United States, Colorado
Aurora, Colorado, United States, 80045
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00400361     History of Changes
Other Study ID Numbers: BO19373 
Study First Received: November 15, 2006
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2016