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NCT Number: NCT01605526

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

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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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5045337

Drug

Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles

Doxorubicin

Drug

60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles

Primary outcomes

  1. Maximum tolerated dose/dose-limiting toxicities

    Time frame: approximately 12 months

  2. Safety: Incidence of adverse events

    Time frame: approximately 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 25, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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