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临床试验/NL-OMON49312
NL-OMON49312招募中2 期

DOMEC - phase II trial of Durvalumab (MEDI4736) and Olaparib in Metastatic/recurrent Endometrial Cancer, a DGOG trial - - DOMEC

Academisch Medisch Centrum0 个研究点目标入组 55 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
入组人数
55
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

年龄范围
18 至 99（—）

入选标准

  • •1. Must provide written informed consent prior to performance of study-specific
  • •procedures or
  • •assessments, and must be willing to comply with treatment and follow-up
  • •assessments.
  • •2. Age > 18 years old
  • •3. Histologically confirmed diagnosis of endometrial cancer or carcinosarcoma
  • •of the endometrium. Besides central revision, a tumor block or 20 slides are
  • •asked for TR.
  • •4. Metastatic disease or locally advanced tumor not amenable to local therapy.
  • •5. Documented progressive disease before enrolment.
  • •6. Measurable lesions outside irradiated field or progressive measurable
  • •lesions in irradiated area
  • •7. Not eligible for hormonal therapy (because of negative hormone receptor/poor
  • •differentiation, or after failure of hormonal therapy).
  • •8. Previous failure of chemotherapy, or refusal to undergo chemotherapy or
  • •chemo-naive patients not suitable for chemotherapy.
  • •9. WHO performance 0-1
  • •10. Adequate organ system function as measured within 28 days prior to
  • •administration of study treatment, as defined below:
  • •* Haemoglobin >= 10.0 g/dL, with no blood transfusion in the past 28 days.
  • •* Absolute neutrophil count (ANC) >= 1.5 x 109/L
  • •* Platelet count >= 100 x 109/L
  • •* Total bilirubin <= 1.5 x institutional upper limit of normal (ULN) (not
  • •applicable to Gilbert's syndrome)
  • •* Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase
  • •(SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase
  • •(SGPT)) <= 2.5 x ULN unless liver metastases are present in which case they must
  • •be <= 5x ULN
  • •* Patients must have creatinine clearance estimated of >=51 mL/min estimated
  • •using the Cockcroft-Gault equation or 24 hr urine clearance :
  • •11. Expected adequacy of follow-up
  • •12. Life expectancy of at least 16 weeks.
  • •13. Measurable disease as defined by RECIST 1.1 criteria
  • •14. Able to swallow and retain oral medication.
  • •15. Body weight > 30 kg

排除标准

  • •1. Participation in another clinical study with an investigational product
  • •during the last month or
  • •previous enrolment in the present study.
  • •2. Any previous treatment with PARP inhibitor, including olaparib and/or any
  • •previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
  • •3. History of another primary malignancy that could conceivably be active
  • •evaluated by the study physician. except for Examples include, but are not
  • •limited to:
  • •* Malignancy treated with curative intent and with no known active disease >=5
  • •years before the first dose of IP and of low potential risk for recurrence.
  • •* Adequately treated non-melanoma skin cancer or lentigo maligna without
  • •evidence of disease
  • •* Adequately treated carcinoma in situ without evidence of disease.
  • •4. History of leptomeningeal carcinomatosis. Patients with symptomatic
  • •uncontrolled brain metastases. A scan to confirm the absence of brain
  • •metastases is not required. The patient can receive a stable dose of
  • •corticosteroids (maximum 2 mg/day) before and during the study as long as these
  • •were started at least 4 weeks prior to treatment. Patients with spinal cord
  • •compression unless considered to have received definitive treatment for this
  • •and evidence of clinically stable disease for 28 days.
  • •5. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour
  • •period or family history of long QT syndrome
  • •6. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole,
  • •telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or
  • •cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or
  • •moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem,
  • •fluconazole, verapamil). The required washout period prior to starting olaparib
  • •is 2 weeks.
  • •7. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin,
  • •rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John*s
  • •Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The
  • •required washout period prior to starting olaparib is 5 weeks for enzalutamide
  • •or phenobarbital and 3 weeks for other agents.
  • •8. Any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy
  • •with the exception of alopecia, vitiligo, and the laboratory values defined in
  • •the inclusion criteria
  • •* Patients with Grade >=2 neuropathy will be evaluated on a case-by-case basis
  • •after consultation with the Study Physician.
  • •* Patients with irreversible toxicity not reasonably expected to be exacerbated
  • •by treatment with durvalumab and olaparib may be included only after
  • •consultation with the Study Physician.
  • •9. Current or prior use of immunosuppressive medication within 14 days before
  • •the first dose of durvalumab, with the exceptions of intranasal and inhaled
  • •corticosteroids or systemic corticosteroids at physiological doses, which are
  • •not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • •10. Major surgery within 2 weeks of starting study treatment and patients must
  • •have recovered from any effects of any major surgery.
  • •11. Patients considered a poor medical risk due to a serious, uncontrolled
  • •medical disorder, non-malignant systemic disease or active, uncontrolled
  • •infection. Examples include, but are not limited to, uncontrolled ventricular

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