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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01605526
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: RO5045337 Drug: doxorubicin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Single Arm 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

Primary Outcome Measures :
  1. Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately 12 months ]
  2. Safety: Incidence of adverse events [ Time Frame: approximately 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01605526

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United States, California
Santa Monica, California, United States, 90403
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
Bordeaux, France, 33076
Lyon, France, 69373
Toulouse, France, 31059
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01605526     History of Changes
Other Study ID Numbers: NP28021
2011-006279-21 ( EudraCT Number )
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action