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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 7, 2013
Last verified: May 2013
History of Changes

August 16, 2007
May 7, 2013
September 2007
April 2014   (final data collection date for primary outcome measure)
  • 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 ]
Phase 1: Incidence of dose-limiting toxicity. Phase 2: Overall best response rate.
Complete list of historical versions of study NCT00517530 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Complete and partial response rates, progression-free survival. Safety: AEs, lab parameters. Pharmacokinetic and pharmacodynamic parameters.
Not Provided
Not Provided
 
A Dose-Escalating Study of RO5072759 in Patients With CD20+ Malignant Disease (GAUGUIN)
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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: RO5072759
Administered iv at escalating doses until evidence of dose-limiting toxicity.
Experimental: 1
Intervention: Drug: RO5072759
Salles G, Morschhauser F, Lamy T, Milpied N, Thieblemont C, Tilly H, Bieska G, Asikanius E, Carlile D, Birkett J, Pisa P, Cartron G. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood. 2012 May 31;119(22):5126-32. Epub 2012 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
134
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00517530
BO20999
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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