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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

Thank you

Trial Information

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


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
- 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose/dose-limiting toxicities

Outcome Time Frame:

approximately 12 months

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NP28021

NCT ID:

NCT01605526

Start Date:

May 2012

Completion Date:

June 2013

Related Keywords:

  • Sarcoma
  • Sarcoma

Name

Location

Fountain Valley, California  92708
Philadelphia, Pennsylvania  19104
Hackensack, New Jersey  07601
Boston, Massachusetts  
Salt Lake City, Utah  84112