Metastatic Breast CancerPhase 1/2NCT02723877
PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)
A Phase 1/2 study testing PQR309 and Eribulin in people with Metastatic Breast Cancer, run by PIQUR Therapeutics AG at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- PQR309 and Eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 28 Mar 2016to 3 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Spain3 sites
Hospital Universitarsi Vall d'Hebron
Barcelona, Catalan, 08035
Insitut Català d´Oncologia
Barcelona
Fundación Instituto Valenciano de Oncología
Valencia
United Kingdom2 sites
Barts Cancer Institute
London
Churchill hospital
Oxford
About this study
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
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).
Read the detailed description
- 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- PQR309, Eribulin
- Keywords
- TNBC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PQR309Drug
Dual phosphatidylinositol 3-kinase phosphoinositide 3-kinase/ mammalian target of rapamycin Inhibitor (= PI3K/mTOR Inhibitor)
EribulinDrug
Also called eribulin mesylate, Halaven®
non.taxane microtubule dynamics inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PQR309; Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Continous dosing and intermittent schedules of PQR309
Measured: 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.
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Assessment of PQR309 and Eribulin blood concentration
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Physical examination, Body weight in kg
Continous dosing and intermittent schedules
Measured: up to 12 months
Physical examination, ECG
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Vital signs like heart rate
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Vital signs like blood pressure
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Vital signs like body temperature
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Objective Response Rate (ORR), is defined as the best overall response (confirmed CR or PR) recorded for each patient since baseline.
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
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)
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
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.
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Progression- free survival (PFS) is defined as the time from study entry to progression or death due to any cause
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Time to treatment failure (TTF) is defined as the time from study entry to any treatment failure including disease progression or discontinuation of treatment
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
1-year survival, defined as the time from study entry to death as a result of any cause at 1-year cut-off date
Continous dosing and intermittent schedules of PQR309
Measured: up to 12 months
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax
Intermittent schedule B: "Monday/ Thursday"
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax
Intermittent schedule B: "Monday/ Thursday"
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24
Intermittent schedule B: "Monday/ Thursday"
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞
Intermittent schedule B: "Monday/ Thursday"
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC(Racemate)
Intermittent schedule B: "Monday/ Thursday"
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax
Intermittent schedule A: 2 days on/5 days off
Measured: 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.
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax
Intermittent schedule A: 2 days on/5 days off
Measured: 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.
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24
Intermittent schedule A: 2 days on/5 days off
Measured: 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.
PK parameters of PQR309 and eribulin will include: AUC0-∞
Intermittent schedule A: 2 days on/5 days off
Measured: 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.
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC
Intermittent schedule A: 2 days on/5 days off
Measured: 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.
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax
Continous Dosing
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24
Continous Dosing
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞
Continous Dosing
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: t1/2
Continous Dosing
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax
Continous Dosing
Measured: 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
Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC (Racemate)
Continous Dosing
Measured: 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
Changes in glucose levels
Continous dosing and intermittent schedules of PQR309
Measured: 12 months
Changes in Insulin levels
Continous dosing and intermittent schedules of PQR309
Measured: 12 months
Changes of Routine laboratory -Haematology
Continous dosing and intermittent schedules of PQR309
Measured: 12 months
Changes of Routine laboratory -blood chemistry
Continous dosing and intermittent schedules of PQR309
Measured: 12 months
Changes of Routine laboratory -urinanalysis
Continous dosing and intermittent schedules of PQR309
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start28 Mar 2016
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- PIQUR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Ramon y Cajal, Hospital Universitari Vall d'Hebron Research Institute, Institut Català d'Oncologia, Churchill Hospital, Barts Cancer Institute, Fundación Instituto Valenciano de Oncología
- Responsible party
- Sponsor
- Investigators
- Javier Cortes, PD Dr. med, Study director, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723877
- Sponsor's protocol ID
- PQR309-007
- Status last verified
- Mar 2019
- First submitted
- 21 Dec 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02723877
- Acronym / sponsor ID
- PQR309-007
- Conditions
- Metastatic Breast Cancer
- Keywords
- TNBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PIQUR Therapeutics AGIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Ramon y Cajal, Hospital Universitari Vall d'Hebron Research Institute, Institut Català d'Oncologia, Churchill Hospital, Barts Cancer Institute, Fundación Instituto Valenciano de Oncología
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin and PQR309 | Experimental | Drug: PQR309, Drug: EribulinPQR309 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PQR309Dual phosphatidylinositol 3-kinase phosphoinositide 3-kinase/ mammalian target of rapamycin Inhibitor (= PI3K/mTOR Inhibitor) | Drug | Eribulin and PQR309 |
| EribulinAlso: eribulin mesylate, Halaven®non.taxane microtubule dynamics inhibitor | Drug | Eribulin and PQR309 |
Primary outcome
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
35 secondary outcomes
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
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
Assessment of PQR309 and Eribulin blood concentration
Time frame: up to 12 months
Physical examination, Body weight in kg
Time frame: up to 12 months
Physical examination, ECG
Time frame: up to 12 months
Vital signs like heart rate
Time frame: up to 12 months
Vital signs like blood pressure
Time frame: up to 12 months
Vital signs like body temperature
Time frame: up to 12 months
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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
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
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
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
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
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
Changes in glucose levels
Time frame: 12 months
Changes in Insulin levels
Time frame: 12 months
Changes of Routine laboratory -Haematology
Time frame: 12 months
Changes of Routine laboratory -blood chemistry
Time frame: 12 months
Changes of Routine laboratory -urinanalysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Cortes, PD Dr. med study director
Hospital Universitario Ramon y Cajal
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PQR309 and Eribulin in people with Metastatic Breast Cancer, run by PIQUR Therapeutics AG at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment related Adverse Events and Serious Adverse Events as assessed by NCI CTCAEV4.03 (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.