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

NCT ID: NCT01677780

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-28
• Study Completion Date: 2017-06-26

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.

Conditions

Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RO5045337

Participants will continue the most similar dose and formulation available (which does not exceed the 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 their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).

Group Type: EXPERIMENTAL

RO5045337

Intervention Type: DRUG

Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m\^2) to 1800 mg/m\^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.

Interventions

RO5045337

Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m\^2) to 1800 mg/m\^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.

Intervention Type: DRUG

Other Intervention Names

MDM2 ANTAGONIST

Eligibility Criteria

Inclusion Criteria

• Participants 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 parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)

Exclusion Criteria

• Participants who developed disease progression/ requiring other anti-tumor therapy while in the parent protocol
• Participants who have stopped study drug dosing for greater than 56 days
• Participants continuing to require dose modifications
• Participants with worsening adverse events
• Participants 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Sarcoma Oncology Center

Santa Monica, California, United States

M.D Anderson Cancer Center; Oncology

Houston, Texas, United States

Cancer Therapy & Research Ctr; Dept Institute for Drug Development

San Antonio, Texas, United States

Princess Margaret Hospital, Medical Oncology & Haematology

Toronto, Ontario, Canada

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, , France

Countries

United States; Canada; France

Other Identifiers

2012-001303-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP28366

Identifier Type: -

Identifier Source: org_study_id