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Ph II Cabazitaxel DD Liposarcoma

NCT01913652 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-09-14

No results posted yet for this study

Summary

Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (\> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.

Conditions

  • Dedifferentiated Liposarcoma

Interventions

DRUG

Cabazitaxel

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Larry Hayward, MD · Western General Hospital, Edinburgh, United Kingdom

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Belgium
  • France
  • Italy
  • United Kingdom

Study Locations

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Entities

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 NCT01913652 on ClinicalTrials.gov