NCT01605526

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2012

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

May 4, 2012

Last Update Submit

November 1, 2016

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose/dose-limiting toxicities

    approximately 12 months

  • Safety: Incidence of adverse events

    approximately 12 months

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: RO5045337Drug: doxorubicin

Interventions

RO5045337DRUG

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

Single Arm
doxorubicinDRUG

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

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Santa Monica, California, 90403, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19111, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132-0001, United States

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Lyon, 69373, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 25, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(4)US(5)