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

NCT02723877 | Completed Phase 1

• 1 other identifier: PQR309-007
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 5

Brief 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

Metastatic Breast Cancer

Keywords

TNBC

Outcome Measures

Primary Outcomes (2)

• Number of patients with treatment related Adverse Events and Serious Adverse Events as assessed by NCI CTCAEV4.03

  Continous dosing and intermittent schedules of PQR309

  Up to 6 months

• RECIST the Response criteria for solid tumors will be used to identify clinical benefit rate (CBR) including complete Response (CR), partial Response (PR) and stable disease (SD)

  Continous dosing and intermittent schedules of PQR309

  Up to 15 months

Secondary Outcomes (35)

• Number of patients with Adverse Events and Serious Adverse Events and number of anormal laboratory values that constitute an Adverse Events on their own

  Up to 12 months

• Number and percent of patients having each ECOG (Eastern Oncology Cooperative Group) performance status level will be presented for baseline and each post-baseline measurement.

  up to 12 months

• Assessment of PQR309 and Eribulin blood concentration

  up to 12 months

• Physical examination, Body weight in kg

  up to 12 months

• Physical examination, ECG

  up to 12 months

Study Arms (1)

Eribulin and PQR309

EXPERIMENTAL

PQR309 in combination with standard approved dose of eribulin mesylate 1.4 mg/m2 intravenous (iv) on days 1 and 8 in a period of 21 days per cycle will be investigated. . PQR309 will be administered maximum 15 minutes after eribulin iv dosing.

Drug: PQR309; Drug: Eribulin

Interventions

PQR309 DRUG

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

Eribulin and PQR309

Eribulin DRUG

non.taxane microtubule dynamics inhibitor

Also known as: eribulin mesylate, Halaven®

Eribulin and PQR309

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/cytologically confirmed diagnosis of breast cancer. Radiological evidence of inoperable locally advanced or metastatic breast cancer.
• HER2 negative breast cancer (based on the most recent analyzed biopsy) defined as a negative in situ hybridization test or an immunohistochemistry status of 0, 1+ or 2+.
• Received at least 2 and no more than 5 prio chemotherapeutic regimens in locally advanced and/or metastatic setting.
• Prior therapy has to include an anthracycline and a taxane in any combination or order.
• For Expansion part:
• Triple-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0,1+ or 2+ER abnd PR status \<10% by local laboratory testing.

You may not qualify if:

• Previous systemic treatment with PI3K,mTOR or AKT inhibitors (allowed in the escalation part).
• Previous treatment with eribulin (allowed in the escalation part). Known hypersensitivity to any of the excipients of PQR309 or eribulin.Concurrent treatment with other approved or investigational antineoplastic agent.
• Symptomatic Central Nervous System metastases. The patient must have completed any prior local treatment for CNS metastases \> 28 days prior to first dose of the study drug (including radiotherapy and/or surgery).
• Clinically manifested diabetes mellitus(treated and/or clinical signs with fasting glucose \>125mg/dl or HbA1c\>7%), or documented steroid induced diabetes mellitus.

Sponsors & Collaborators

• PIQUR Therapeutics AG: lead
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: collaborator
• Institut Català d'Oncologia: collaborator
• Churchill Hospital: collaborator
• Barts Cancer Institute: collaborator
• Fundación Instituto Valenciano de Oncología: collaborator

Study Sites (5)

Hospital Universitarsi Vall d'Hebron

Barcelona, Catalan, 08035, Spain

Location

Insitut Català d´Oncologia

Barcelona, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, Spain

Location

Barts Cancer Institute

London, United Kingdom

Location

Churchill hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Javier Cortes, PD Dr. med

  Hospital Universitario Ramon y Cajal

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: March 31, 2016
• Study Start: March 28, 2016
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

GB (2); ES (3)