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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00400361
First received: November 15, 2006
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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 seque ntially enrolled to receive ascending doses of R1507 either weekly or three-week ly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regim en will be escalated in subsequent groups of patients after a satisfactory asses sment of safety, tolerability and pharmacokinetics of the previous dose. The ant icipated time on study treatment is until disease progression or dose-limiting t oxicity, and the target sample size is <100 individuals.


Condition Intervention Phase
Neoplasms
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).

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: October 6, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014