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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01605526
Collaborator
(none)
23
Enrollment
9
Locations
1
Arm
13
Duration (Months)
2.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose/dose-limiting toxicities [approximately 12 months]

  2. Safety: Incidence of adverse events [approximately 12 months]

Secondary Outcome Measures

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Monica California United States 90403
2 Boston Massachusetts United States 02115
3 Hackensack New Jersey United States 07601
4 Philadelphia Pennsylvania United States 19111
5 Salt Lake City Utah United States 84132-0001
6 Bordeaux France 33076
7 Lyon France 69373
8 Toulouse France 31059
9 Villejuif France 94805

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01605526
Other Study ID Numbers:
  • NP28021
  • 2011-006279-21
First Posted:
May 25, 2012
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Sarcoma
Doxorubicin

Study Results

No Results Posted as of Nov 2, 2016