Back to resultsA Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO5045337
doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed soft tissue sarcoma
- Evaluable disease according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Eligible for doxorubicin therapy
- Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
- Adequate bone marrow, hepatic and renal function
- Patients with stable CNS metastases are eligible
Exclusion Criteria:
- Previous treatment with limiting doses of doxorubicin
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
- History of seizure disorders or unstable CNS metastases
- Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
- HIV positive patients who are currently receiving combination anti-retroviral therapy
- Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
- Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose/dose-limiting toxicities
Safety: Incidence of adverse events
Secondary Outcome Measures
Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)
Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01605526
Brief Title
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Official Title
A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (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 multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5045337
Intervention Description
Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles
Primary Outcome Measure Information:
Title
Maximum tolerated dose/dose-limiting toxicities
Time Frame
approximately 12 months
Title
Safety: Incidence of adverse events
Time Frame
approximately 12 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)
Time Frame
Pre-dose and up to 72 hours post-dose Days 1 and 5 of Cycle 1
Title
Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels
Time Frame
Pre-dose and up to 72 hours post-dose on Days 1 and 5 of Cycle 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
Histologically or cytologically confirmed soft tissue sarcoma
Evaluable disease according to RECIST version 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Eligible for doxorubicin therapy
Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
Adequate bone marrow, hepatic and renal function
Patients with stable CNS metastases are eligible
Exclusion Criteria:
Previous treatment with limiting doses of doxorubicin
Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
History of seizure disorders or unstable CNS metastases
Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
Pregnant or breastfeeding women
HIV positive patients who are currently receiving combination anti-retroviral therapy
Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0001
Country
United States
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
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