Spots Global Cancer Trial Database for An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies

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Trial Identification

Brief Title: An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies

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

Study ID: NCT01677780

Conditions

Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

Interventions

RO5045337

Study Description

Brief Summary: 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.

Detailed Description: