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:
Hoffmann-La Roche
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
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Purpose
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.
| 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677780
Contacts
| Contact: Please reference Study ID Number: NP28366 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, California | |
| Active, not recruiting | |
| Santa Monica, California, United States, 90403 | |
| United States, Maryland | |
| Recruiting | |
| Rockville, Maryland, United States, 20850-3348 | |
| United States, Texas | |
| Active, not recruiting | |
| Houston, Texas, United States, 77030 | |
| Active, not recruiting | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Ontario | |
| Recruiting | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| France | |
| Completed | |
| Toulouse, France, 31052 | |
| Italy | |
| Not yet recruiting | |
| Bologna, Italy, 40138 | |
| United Kingdom | |
| Not yet recruiting | |
| Glasgow, United Kingdom, G12 0YN | |
| Not yet recruiting | |
| Manchester, United Kingdom, M204BX | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01677780 History of Changes |
| Other Study ID Numbers: | NP28366, 2012-001303-20 |
| Study First Received: | August 30, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Acute Disease Chronic Disease |
Neoplasms by Histologic Type Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013