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A Dose-Escalating Study of RO5072759 in Patients With CD20+ Malignant Disease (GAUGUIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517530
First received: August 16, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will investigate the safety and tolerability of intravenous R7159 monotherapy, in patients with CD20+ malignant disease. Having identified the recommended dose for further investigation, the efficacy and safety of this dose will be investigated in 4 different patient populations: diffuse large beta-cell lymphoma (DLBCL), follicular non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Lymphoma
 Drug: RO5072759
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicentre,Dose-escalating Phase I/II Study, With a Randomised Phase II Part, to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20+ Malignant Disease

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Phase 1: Incidence of dose-limiting toxicity. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Phase 2: Overall response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete and partial response rates, progression-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, pharmacokinetic and pharmacodynamic parameters. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: September 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5072759
Administered iv at escalating doses until evidence of dose-limiting toxicity.

  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;
  • part 1 only: CD20+ malignant disease (lymphoma or CLL);
  • part 2 only: relapsed or refractory DLBCL, follicular NHL, CLL or MCL.

Exclusion Criteria:

  • prior use of any investigational antibody therapy or other agent within 6 months of study start;
  • prior use of any anti-cancer vaccine;
  • prior use of MabThera within 8 weeks of study entry;
  • CNS lymphoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517530

Locations
France
Creteil, France, 94010
Le Mans, France, 72015
Lille, France, 59037
Marseille, France, 13273
Montpellier, France, 34295
Nantes, France, 44093
Paris, France, 75651
Paris, France, 75475
Pessac, France, 33604
Pierre Benite, France, 69495
Rennes, France, 35033
Rouen, France, 76038
Toulouse, France, 31059
Tours, France, 37044
Vandoeuvre Les Nancy, France, 54511
Germany
Köln, Germany, 50924
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517530     History of Changes
Other Study ID Numbers: BO20999
Study First Received: August 16, 2007
Last Updated: May 23, 2013
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013