EUCTR2015-004225-14-GB进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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. 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, phosphate, 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.
- •- Fasting plasma glucose = 125 mg/dL (= 7 mmol/L).
- •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% (equivalent to Allred score of 2 or less) 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
排除标准
- •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 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 rand
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