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An Extension Study of RO5045337 in Patients Participating in Previous Cancer Studies

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677780
First received: August 30, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

August 30, 2012
May 7, 2013
November 2012
September 2014   (final data collection date for primary outcome measure)
Long-term safety: incidence of adverse events [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01677780 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Extension Study of RO5045337 in Patients Participating in Previous Cancer Studies
A Multi-center, Open Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-sponsored Phase 1 Cancer Studies.

This open-label, extension study is designed to provide access to RO5045337 to patients who have completed studies NO21279, NO21280, NP25299, NP28021 or NP28023. Patients are eligible to participate in this study (NP28366) if they have shown clinical benefit on treatment of RO5045337 at the completion of their respective parent study. Patients will continue on the same formulation, dose and schedule of RO5045337 they were receiving at the time of transitioning from the parent clinical study protocol. The anticipated time on study treatment is 12 months.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
Drug: RO5045337
Patients will continue on the same formulation, dose and schedule of RO5045337 they were receiving at the time of transitioning from the parent clinical study protocol.
Experimental: RO5045337
Intervention: Drug: RO5045337
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must meet the inclusion criteria outlined in the parent protocol: NO21279, NO21280, NP25299, NP28021 or NP28023
  • Patients must have completed one of the following clinical study protocols and have been determined to have clinical benefit on treatment at the conclusion of required study analyses as defined in the respective protocols: NO21279, NO21280, NP25299, NP28021 or NP28023

Exclusion Criteria:

  • Patients must meet the exclusion criteria outlined in the parent protocol: NO21279, NO21280, NP25299, NP28021 or NP28023
  • Patients who developed disease progression/ requiring other anti-tumor therapy while in the parent protocol
  • Patients who have stopped study drug dosing for greater than 56 days.
  • Patients continuing to require dose modifications
  • Patients with worsening adverse events.
  • Patients with unrelated adverse events, medical illnesses, or changes in performance status that, per investigator discretion, put them at high risk for continuing participation in the clinical study
Both
18 Years and older
No
Contact: Please reference Study ID Number: NP28366 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States,   Canada,   France,   Italy,   United Kingdom
 
NCT01677780
NP28366, 2012-001303-20
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