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Trabectedin Plus Olaparib in Metastatic or Advanced Sarcomas (TOMAS)

NCT02398058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-14

No results posted yet for this study

Summary

This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the safety, tolerability, and pharmacokinetics of escalating doses of olaparib and trabectedin in patients with unresectable advanced/metastatic sarcomas. Patients will continue to be treated on this combination regimen in the absence of disease progression, intolerable toxicity or patient's decision.

Conditions

  • Soft Tissue Sarcoma
  • Bone Tumor

Interventions

DRUG

trabectedin

trabectedin will be administered in a 24-h continuous i.v. infusion every 3 weeks

DRUG

olaparib

olaparib will be administered in a continuous daily dose every 12 hours

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • Italian Sarcoma Group

    lead NETWORK

Principal Investigators

  • Giovanni Grignani, MD · Italian Sarcoma Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-20
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398058 on ClinicalTrials.gov