Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2015-004225-14-ES
EUCTR2015-004225-14-ESActive, not recruitingPhase 1

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 - PQR309-007

PIQUR Therapeutics AG0 sites31 target enrollmentStarted: November 12, 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
31
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •1. Female ? 18 years old at the time of informed consent.
  • •2. Histologically/cytologically confirmed diagnosis of breast cancer.
  • •3. Radiological evidence of inoperable locally advanced or metastatic breast cancer.
  • •4. HER2 negative breast cancer (based on the most recent analyzed biopsy) defined as a negative in situ hybridization test (ISH) or an immunohistochemistry (IHC) status of 0, 1+ or 2+ (if IHC 2+, a negative in situ hybridization test is required) by local laboratory testing.
  • •5. Negative estrogen receptor and progesterone receptor status known as per local laboratory testing.
  • •6. Received at least 2 and no more than 5 prior chemotherapeutic regimens in locally advanced and/or metastatic setting. Prior therapy has to include an anthracycline and a taxane in any combination or order (unless contraindicated for a certain patient). Prior anti-hormonal therapy is allowed.
  • •7. Stable Eastern Cooperative Oncology Group (ECOG) performance status ? 2.
  • •8. More than 4 weeks from any investigational agent.
  • •9. Adequate bone marrow and organ function as defined by the following laboratory values:
  • •- Absolute neutrophil count (ANC) ? 1.5x10^9/l, platelets ? 100x10^9/l, hemoglobin ? 100g/L.
  • •- Potassium, calcium (corrected for serum albumin) and magnesium within normal limits (WNL) for the institution.
  • •- Total bilirubin ? 1.5 times the upper limit of normal (ULN).
  • •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? 2.5 times ULN or ? 5.0 x ULN if liver metastases are present.
  • •- Serum creatinine ? 1.5 times ULN.
  • •- Fasting plasma glucose ? 125 mg/dL (? 7 mmol/L) or HbA1c ? 7%.
  • •10. Able and willing to swallow and retain oral medication.
  • •11. Written informed consent obtained according to local guidelines.
  • •Expansion part:
  • •12. Triple-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+ (if IHC 2+, a negative in situ hybridization is required), ER and PR status < 10% by local laboratory testing.
  • •13. Measurable disease according to RECIST v.1.1 or non-measurable lytic or mixed (lytic + blastic) bone lesions with an identifiable soft tissue component that meets the measurability criteria per RECIST v.1.1
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 31
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

  • •1. Previous systemic treatment with PI3K, mTOR or AKT inhibitors (allowed in the escalation part).
  • •2. Previous treatment with eribulin (allowed in the escalation part).
  • •3. Known hypersensitivity to any of the excipients of PQR309 or eribulin.
  • •4. Concurrent treatment with other approved or investigational antineoplastic agent.
  • •5. Symptomatic CNS 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).
  • •6. Clinically manifested diabetes mellitus (treated and/or clinical signs with fasting glucose > 125 mg/dl or HbA1c >7%), or documented steroid induced diabetes mellitus.
  • •7. Peripheral neuropathy ? CTC AE grade 2.
  • •8. Anxiety ? CTC AE grade 3.
  • •9. Concurrent malignancy other than HER2 negative BC or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer).
  • •10. Received radiotherapy ? 3 weeks or limited field radiation for palliation ? 2 weeks prior to starting study drug, and not recovered or improved to grade 1 from related side effects of such therapy (exceptions include alopecia) and/or from whom ? 30% of the bone marrow was irradiated.
  • •11. Not recovered or improved to grade 1 from related side effects (except alopecia) of any prior antineoplastic therapy.
  • •12. Major surgery within 14 days prior to first dose of the study drug or not recovered from major side effects.
  • •13. Received systemically high doses of corticosteroids ? 2 weeks prior to starting study drug, or not fully recovered from side effects of such treatment.
  • •Stable doses of corticosteroids, no more than 1 mg of dexamethasone a day or equivalent, e.g. 6 mg prednisone or 25 mg hydrocortisone for at least 5 days prior to first dose of the study drug is allowed.
  • •14. Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
  • •15. Treatment with medicinal products that increase the pH (reduce acidity) of the upper Gastro-Intestinal (GI) tract, including, but not limited to: protonpump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a wash out period sufficient to terminate their effect.
  • •16. Using herbal preparations or medications within ? 7 days prior to first dose of the study drug.
  • •17. Any severe or uncontrolled cardiac disease or history of cardiac dysfunction (Section 9.3 of protocol).
  • •18. Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
  • •19. Cardiac conduction abnormalities (Section 9.3 of protocol).
  • •20. QTcF > 480 msec on the screening ECG (using the QTcF formula).
  • •21. Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to randomization.
  • •22. Impairment of hepatic function (Child-Pugh score > 5).
  • •23. Severe impairment of kidney function (CrCL: 15-29 mL/min - according to Cockcroft-Gault formula).
  • •24. Gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PQR309.
  • •25. Any other concurrent severe and/or uncontrolled medical condition that would, in

Investigators

Similar Trials

Active, not recruiting
Phase 1
Study investigating safety and efficacy of PQR309 and eribulin combination in patients with locally advanced or metastatic HER2 negative and triple-negative breast cancer
EUCTR2015-004225-14-GBPIQUR Therapeutics AG31
Active, not recruiting
Not Applicable
An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) in patients with follicular non Hodgkin’s lymphoma with no prior treatment - FL2008 RGM
EUCTR2007-005580-95-FRGoelams
Active, not recruiting
Not Applicable
An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with RCHOP chemotherapy and Rituximab (MabThera®) maintenance in patients with first-line advanced follicular non Hodgkin’s lymphoma - FL2008 RCHOPGMThis study evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) and chemotherapy (CHOP) in patients with non bulky follicular non Hodgkin’s lymphoma with no prior treatment.MedDRA version: 9.1Level: LLTClassification code 10025310Term: Lymphoma
EUCTR2007-007056-33-FRGoelams
Completed
Not Applicable
A multicenter, Phase 1b, open label, nonrandomized, single dose study evaluating the safety, tolerability and activity of BIVV020 in adults with cold agglutinin diseaseCADcold agglutinin disease10003816
NL-OMON55174Genzyme Europe BV2
Unknown
Phase 2
A multi-center, open label, non-randomized, phase II study to assess the activity and safety of cetuximab plus irinotecan in subjects with EGFR-detectable metastatic colorectal carcinomaColorectal carcinoma
JPRN-jRCT2080220192Bristol-Myers K.K.38