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

Roche

Status and phase

Completed

Phase 1

Conditions

Sarcoma

Treatments

Drug: doxorubicin

Drug: RO5045337

Study type

Interventional

Funder types

Industry

Identifiers

NCT01605526

2011-006279-21 (EudraCT Number)

NP28021

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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