Trabectedin Plus Olaparib in Metastatic or Advanced Sarcomas (TOMAS)

Sponsor
Italian Sarcoma Group
Study ID
NCT02398058
Phase
PHASE1
Status
Completed

Conditions

  • Bone Tumor
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • trabectedin — DRUG
    trabectedin will be administered in a 24-h continuous i.v. infusion every 3 weeks
  • olaparib — DRUG
    olaparib will be administered in a continuous daily dose every 12 hours

Study Details

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.

Key Dates

Start date
Jul 20, 2014
Status verified
Apr 2021
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trabectedin plus olaparib
    All patients will be treated with trabectedin and olaparib in an open-label fashion. The dosage of the drugs at which each patient is treated depends on the dose level reached at the time of enrollment.

Primary Outcome Measure

maximum tolerated dose [ Time Frame: from start up to 6 weeks ]

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