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

Primary Purpose

Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RO5045337

About this trial

This is an interventional treatment trial for Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must meet the inclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
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 must meet the exclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
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

Sites / Locations

Sarcoma Oncology Center
M.D Anderson Cancer Center; Oncology
Cancer Therapy & Research Ctr; Dept Institute for Drug Development
Princess Margaret Hospital, Medical Oncology & Haematology
Institut Claudius Regaud; Departement Oncologie Medicale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RO5045337

Arm Description

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).

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Full Information

NCT ID

NCT01677780

First Posted

August 30, 2012

Last Updated

July 5, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01677780

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 Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

November 28, 2012 (Actual)

Primary Completion Date

June 26, 2017 (Actual)

Study Completion Date

June 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RO5045337

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

RO5045337

Other Intervention Name(s)

MDM2 ANTAGONIST

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame

Approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must meet the inclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296) 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 must meet the exclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Sarcoma Oncology Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

Facility Name

M.D Anderson Cancer Center; Oncology

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Cancer Therapy & Research Ctr; Dept Institute for Drug Development

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Princess Margaret Hospital, Medical Oncology & Haematology

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Institut Claudius Regaud; Departement Oncologie Medicale

City

Toulouse

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

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

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