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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
Open (Enrolling)
Both
Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

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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