Trial record 1 of 7 for:    RO5045337
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An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677780
First received: August 30, 2012
Last updated: July 26, 2016
Last verified: July 2016

August 30, 2012
July 26, 2016
November 2012
November 2016   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]
Long-term safety: incidence of adverse events [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01677780 on ClinicalTrials.gov Archive Site
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An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored 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 continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit (as defined by the parent protocol). Participants will continue the most similar dose and formulation available (which does not exceed the maximum tolerated dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
Drug: RO5045337
Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m^2) to 1800 mg/m^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.
Other Name: MDM2 ANTAGONIST
Experimental: RO5045337
Participants will continue the most similar dose and formulation available (which does not exceed the MTD or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).
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.
 
Active, not recruiting
11
November 2016
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants must meet the inclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
  • Participants 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 parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)

Exclusion Criteria:

  • Participants must meet the exclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
  • Participants who developed disease progression/ requiring other anti-tumor therapy while in the parent protocol
  • Participants who have stopped study drug dosing for greater than 56 days
  • Participants continuing to require dose modifications
  • Participants with worsening adverse events
  • Participants 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France
Italy,   United Kingdom
 
NCT01677780
NP28366, 2012-001303-20
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

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