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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 30, 2012
Last updated: November 24, 2014
Last verified: November 2014

This open-label, extension study is designed to provide access to RO5045337 to p atients who have completed studies NO21279, NO21280, NP25299, NP28021 or NP28023 Patients are eligible to participate in this study (NP28366) if they have show n clinical benefit on treatment of RO5045337 at the completion of their respecti ve parent study. Patients will continue on the same formulation, dose and schedu le 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.

Condition Intervention Phase
Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
Drug: RO5045337
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 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Long-term safety: incidence of adverse events [ Time Frame: Approximately 24 months ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO5045337 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.


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

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
  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 identifier: NCT01677780

United States, California
Santa Monica, California, United States, 90403
United States, Maryland
Rockville, Maryland, United States, 20850
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Lyon, France, 69373
Marseille, France, 13273
Toulouse, France, 31059
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01677780     History of Changes
Other Study ID Numbers: NP28366, 2012-001303-20
Study First Received: August 30, 2012
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms by Histologic Type processed this record on November 27, 2014