Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib(BKM120) plus paclitaxel vs. placebo plus paclitaxel inpatients with platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma.

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 2 期
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Patient is greater than or equal to 18 years old;
•2. Written informed consent obtained before any trial related activities and according to local
•guidelines.
•3. Patient has histologically/cytologically-confirmed HNSCC.
•4. Patient has archival or fresh tumor tissue for the analysis of PI3K-related biomarkers. One
•tumor block (preferred) or a minimum of 15 unstained slides to be provided. Enrollment in
•the study is contingent on the central laboratory confirming receipt of an adequate amount of tissue.
•5. Patients with recurrent or metastatic disease after failure to platinum-based chemotherapy
•(defined as progression while on or after platinum-based chemotherapy given in the
•recurrent/metastatic setting). Pretreatment with cetuximab (as part of chemoradiation,
•first-line therapy or maintenance, or as single agent second line regimen) is allowed
•6. Measurable disease as determined by per RECIST criteria v1.1. If the only site of
•measurable disease is a previously irradiated lesion, documented progression of disease
•and a 4 week period since radiotherapy completion is required
•7. Adequate bone marrow function and organ function as shown by:
•Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 raised to 9 per L
•Hemoglobin greater than or equal to 9 g per dl (which may be reached by transfusion)
•Platelets greater than or equal to 100 x 10 raised to 9 per L (which may be reached by transfusion)
•INR less than or equal to 1.5
•Potassium, calcium (corrected for serum albumin) and magnesium within normal
•limits (WNL) for the institution
•Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) below or
•equal upper limit of normal range (or less than 3 x ULN if liver metastases are present)
•Total serum bilirubin below or equal upper limit of normal range (or less than or eual to 1.5 x ULN if liver metastases are present; or total bilirubin less than or equal to 3 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbertâ??s Syndrome, which is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from CBC count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis (see Appendix in the final protocol)
•Serum creatinine less than or equal to 1.5 x ULN or calculated or directly measured CrCl greater than or equal to 50 percent LLN
•(Lower Limit of Normal)
•Fasting plasma glucose (FPG) less than or equal to 120 mg per dL or less than or equal to 6.7 mmol per L
•HbA1c less than or equal to 8 percent
•8. ECOG Performance Status less than or equal to 1
•9. Patient is able to swallow and retain oral medication
•Note: patients able to swallow oral medication but mostly self-nourished through gastric or jejunal feeding tube are eligible

排除标准

•1. Patient received treatment with any AKT, mTOR inhibitors or PI3K pathway inhibitors;
•2. Patient received treatment with a taxane as part prior treatment for metastatic disease
•3. Patient treated with more than 1 prior chemotherapy regimen for recurrent/metastatic
•disease (i.e. chemotherapy, chemotherapy in association with a biologic/targeted agent,)
•Patients treated with adjuvant/neoadjuvant chemotherapy and/or concomitant chemoradiotherapy regimen that may have included biologic/targeted agent are eligible.
•Cetuximab single agent used in metastatic setting is allowed.
•4. Patient has symptomatic CNS metastases. Patients with asymptomatic CNS metastases
•may participate . The patient must have completed any prior local treatment for
•CNS metastases or equal to 28 days prior to the start of study treatment (including radiotherapy and/or surgery) & must have stable low dose of corticosteroid therapy;
•5. Patient who has received wide field radiotherapy or equal to 4 weeks or limited field radiation for palliation or equal to 2 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia)
•6. Patient has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
•7. Patient has had major surgery within 14 days prior to starting study drug or has not
•recovered from major side effects
•8. Patient is currently receiving increasing or chronic treatment (less than 5 days) with
•corticosteroids or another immunosuppressive agent, as chronic administration of
•corticosteroids ( 5 days) can induce CYP3A4
•The following uses of corticosteroids are permitted: single doses; standard
•premedication for paclitaxel; topical applications (e.g., rash), inhaled sprays (e.g.,
•obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
•9. Patient is being treated at start of study treatment with any of the following drugs:
•Drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A4
•including herbal medications
•Drugs with known risk to induce Torsades de Pointes
•Note: The patient must have discontinued strong inducers for at least 1 week & strong inhibitors before the treatment is initiated. Switching to a
•different medication prior to starting study treatment is allowed.
•10. Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for
•treatment, prophylaxis or otherwise. Therapy with heparin, LMWH, or fondaparinux is allowed;
•11. Patient has a known hypersensitivity and/or contra indication to paclitaxel, standard pretreatment for paclitaxel or other products containing Cremophor;
•12. Patients who have other concurrent severe and/or uncontrolled medical conditions that
•would, in the investigatorâ??s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis,
•immunocompromised, acute/chronic pancreatitis, uncontrolled high blood pressure,interstitial lung disease, etc.)
•13. Patient has a known history of HIV infection (testing not mandatory) infection
•14. Patient has any of the following cardiac abnormalities:

研究者

发起方

ovartis Healthcare Pvt Ltd

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