A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Sarcoma |
Intervention | Drug: RO5045337 Drug: doxorubicin |
Phase | Phase 1 |
Sponsor | Hoffmann-La Roche |
Responsible Party | Hoffmann-La Roche |
ClinicalTrials.gov Identifier | NCT01605526 |
First Received | May 4, 2012 |
Last Updated | April 7, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | May 4, 2012 |
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Last Updated Date | April 7, 2014 |
Start Date | May 2012 |
Estimated Primary Completion Date | June 2013 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma |
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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 |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Sarcoma |
Intervention | Drug: RO5045337 Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles Drug: doxorubicin 60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles |
Study Arm (s) | Experimental: Single Arm |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 23 |
Estimated Completion Date | June 2013 |
Estimated Primary Completion Date | June 2013 |
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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01605526 |
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Other Study ID Numbers | NP28021 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Hoffmann-La Roche |
Study Sponsor | Hoffmann-La Roche |
Collaborators | Not Provided |
Investigators | Study Director: Clinical Trials Hoffmann-La Roche |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
United States, California | Santa Monica, California, United States, 90403 |
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United States, Massachusetts | Boston, Massachusetts, United States, 02115 |
United States, New Jersey | Hackensack, New Jersey, United States, 07601 |
United States, Pennsylvania | Philadelphia, Pennsylvania, United States, 19111 |
United States, Utah | Salt Lake City, Utah, United States, 84132-0001 |
France | Bordeaux, France, 33076 |
France | Lyon, France, 69373 |
France | Toulouse, France, 31059 |
France | Villejuif, France, 94805 |