A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

Phase 1

Completed

• Conditions: Sarcoma
• Interventions: Drug: RO5045337; Drug: doxorubicin

• Registration Number: NCT01605526
• Lead Sponsor: Hoffmann-La Roche

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 available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-25
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	RO5045337	-
Single Arm	doxorubicin	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose/dose-limiting toxicities	approximately 12 months
Safety: Incidence of adverse events	approximately 12 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)	Pre-dose and up to 72 hours post-dose Days 1 and 5 of Cycle 1
Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels	Pre-dose and up to 72 hours post-dose on Days 1 and 5 of Cycle 1