PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)
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ClinicalTrials.gov Identifier: NCT02723877 |
Recruitment Status :
Completed
First Posted : March 31, 2016
Last Update Posted : March 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Breast Cancer | Drug: PQR309 Drug: Eribulin | Phase 1 Phase 2 |
- The primary objective of the escalation part is to assess the maximum tolerated dose (MTD) of PQR309 combined with the standard eribulin dose in patients with HER2 negative breast cancer following a "modified" 3 by 3 design.
- For the expansion part the objective is to evaluate efficacy of PQR309 in combination with eribulin in patients with Triple Negative Breast Cancer
- Once the MTD of continuous daily PQR309 dosing has been established, intermittent schedules of PQR309 ("2 days on/ 5 days off" or "Monday / Thursday") will be evaluated.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label, Non Randomized, Multicenter Phase 1/2b Study Investigating Safety and Efficacy of PQR309 and Eribulin Combination in Patients With Locally Advanced or Metastatic HER2 Negative and Triple-Negative Breast Cancer |
Actual Study Start Date : | March 28, 2016 |
Actual Primary Completion Date : | October 3, 2018 |
Actual Study Completion Date : | October 3, 2018 |

Arm | Intervention/treatment |
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Experimental: Eribulin and PQR309
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.
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Drug: PQR309
Dual phosphatidylinositol 3-kinase phosphoinositide 3-kinase/ mammalian target of rapamycin Inhibitor (= PI3K/mTOR Inhibitor) Drug: Eribulin non.taxane microtubule dynamics inhibitor
Other Names:
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- Number of patients with treatment related Adverse Events and Serious Adverse Events as assessed by NCI CTCAEV4.03 [ Time Frame: Up to 6 months ]Continous dosing and intermittent schedules of PQR309
- 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) [ Time Frame: Up to 15 months ]Continous dosing and intermittent schedules of PQR309
- Number of patients with Adverse Events and Serious Adverse Events and number of anormal laboratory values that constitute an Adverse Events on their own [ Time Frame: Up to 12 months ]Continous dosing and intermittent schedules of PQR309
- 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. [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Assessment of PQR309 and Eribulin blood concentration [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Physical examination, Body weight in kg [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules
- Physical examination, ECG [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Vital signs like heart rate [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Vital signs like blood pressure [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Vital signs like body temperature [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Objective Response Rate (ORR), is defined as the best overall response (confirmed CR or PR) recorded for each patient since baseline. [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Time to Response (TTR) is defined, for patients with tumor response, as the time from the date of study entry to the first documentation of response (complete or partial) [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Duration of response (DOR) is defined, for the patients with tumor response, as the time from the date of the first confirmed response to disease progression. [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Progression- free survival (PFS) is defined as the time from study entry to progression or death due to any cause [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Time to treatment failure (TTF) is defined as the time from study entry to any treatment failure including disease progression or discontinuation of treatment [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- 1-year survival, defined as the time from study entry to death as a result of any cause at 1-year cut-off date [ Time Frame: up to 12 months ]Continous dosing and intermittent schedules of PQR309
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax [ Time Frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose ]Intermittent schedule B: "Monday/ Thursday"
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax [ Time Frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose ]Intermittent schedule B: "Monday/ Thursday"
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24 [ Time Frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose ]Intermittent schedule B: "Monday/ Thursday"
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞ [ Time Frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose ]Intermittent schedule B: "Monday/ Thursday"
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC(Racemate) [ Time Frame: On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose ]Intermittent schedule B: "Monday/ Thursday"
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax [ Time Frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose. ]Intermittent schedule A: 2 days on/5 days off
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax [ Time Frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose. ]Intermittent schedule A: 2 days on/5 days off
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24 [ Time Frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose. ]Intermittent schedule A: 2 days on/5 days off
- PK parameters of PQR309 and eribulin will include: AUC0-∞ [ Time Frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose. ]Intermittent schedule A: 2 days on/5 days off
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC [ Time Frame: PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose. ]Intermittent schedule A: 2 days on/5 days off
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax [ Time Frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1 ]Continous Dosing
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24 [ Time Frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1 ]Continous Dosing
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞ [ Time Frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 day on 1 and 8 and beyond cycle 1 on day 1 ]Continous Dosing
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: t1/2 [ Time Frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1 ]Continous Dosing
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax [ Time Frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1 ]Continous Dosing
- Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC (Racemate) [ Time Frame: It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1 ]Continous Dosing
- Changes in glucose levels [ Time Frame: 12 months ]Continous dosing and intermittent schedules of PQR309
- Changes in Insulin levels [ Time Frame: 12 months ]Continous dosing and intermittent schedules of PQR309
- Changes of Routine laboratory -Haematology [ Time Frame: 12 months ]Continous dosing and intermittent schedules of PQR309
- Changes of Routine laboratory -blood chemistry [ Time Frame: 12 months ]Continous dosing and intermittent schedules of PQR309
- Changes of Routine laboratory -urinanalysis [ Time Frame: 12 months ]Continous dosing and intermittent schedules of PQR309

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723877
Spain | |
Hospital Universitarsi Vall d'Hebron | |
Barcelona, Catalan, Spain, 08035 | |
Insitut Català d´Oncologia | |
Barcelona, Spain | |
Fundación Instituto Valenciano de Oncología | |
Valencia, Spain | |
United Kingdom | |
Barts Cancer Institute | |
London, United Kingdom | |
Churchill hospital | |
Oxford, United Kingdom |
Study Director: | Javier Cortes, PD Dr. med | Hospital Universitario Ramon y Cajal |
Responsible Party: | PIQUR Therapeutics AG |
ClinicalTrials.gov Identifier: | NCT02723877 |
Other Study ID Numbers: |
PQR309-007 |
First Posted: | March 31, 2016 Key Record Dates |
Last Update Posted: | March 22, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
TNBC |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |