NCT01677780

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 28, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

4.6 years

First QC Date

August 30, 2012

Last Update Submit

July 5, 2017

Conditions

Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

Outcome Measures

Primary Outcomes (1)

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

    Approximately 24 months

Study Arms (1)

RO5045337

EXPERIMENTAL

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).

Drug: RO5045337

Interventions

RO5045337DRUG

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.

Also known as: MDM2 ANTAGONIST
RO5045337

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

M.D Anderson Cancer Center; Oncology

Houston, Texas, 77030, United States

Location

Cancer Therapy & Research Ctr; Dept Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

Princess Margaret Hospital, Medical Oncology & Haematology

Toronto, Ontario, M5G 2M9, Canada

Location

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Leukemia, MyeloidBronchiolitis Obliterans SyndromeNeoplasms

Interventions

RO6839921

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

November 28, 2012

Primary Completion

June 26, 2017

Study Completion

June 26, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

US(3)FR(1)CA(1)