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.
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
Both
Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Long-term safety: incidence of adverse events
Outcome Time Frame:
Approximately 24 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NP28366
NCT ID:
NCT01677780
Start Date:
November 2012
Completion Date:
July 2014
Related Keywords:
- Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute
- Neoplasms
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Acute Disease
- Chronic Disease
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Austin, Texas 78705 | |
| Baltimore, Maryland 21287 |
