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PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)

NCT02723877 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-03-22

No results posted yet for this study

Summary

This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of eribulin in patients with locally advanced or metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion part).

Conditions

Interventions

DRUG

PQR309

Dual phosphatidylinositol 3-kinase phosphoinositide 3-kinase/ mammalian target of rapamycin Inhibitor (= PI3K/mTOR Inhibitor)

DRUG

Eribulin

non.taxane microtubule dynamics inhibitor

Sponsors & Collaborators

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    collaborator OTHER

  • Institut Català d'Oncologia

    collaborator OTHER

  • Churchill Hospital

    collaborator OTHER

  • Barts Cancer Institute

    collaborator OTHER

  • Fundación Instituto Valenciano de Oncología

    collaborator OTHER

  • PIQUR Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Javier Cortes, PD Dr. med · Hospital Universitario Ramon y Cajal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-28
Primary Completion
2018-10-03
Completion
2018-10-03

Countries

  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02723877 on ClinicalTrials.gov