A Phase 1b, open-label, dose-finding study of CC-90010 in combination with temozolomide with or without radiation therapy in subjects with newly diagnosed glioblastoma - CC-90010-GBM-002

Celgene Corporation0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Celgene Corporation
入组人数: 36

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

•Only part A
•- For Adjuvant Therapy in Part A dose scalation: Subject must have recently
•completed standard or a hypofractionated course of radiotherapy with TMZ
•chemotherapy, and then have an MRI documenting stable disease prior to the
•first dose of CC -90010.
•- For Adjuvant Therapy in Part A dose escalation:
•a. All AEs resulting from prior RT+TMZ chemotherapy must have resolved to
•NCI CTCAE (v5.0) Grade **1 (except for laboratory parameters outlined below
•b. Subject must have not experienced significant toxicity to prior RT+TMZ
•(i.e.,ie, Grade 4 hematological toxicity)
•c. Subject must have received at least 80% of the planned standard doses of RT
•and/or TMZ administered throughout the 42- day concomitant period (up to 49
•- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 in
•Only part B
•- For Part B randomized expansion, only subjects with primary, IDH-wild type
•newly diagnosed WHO Grade IV Glioblastoma will be enrolled. Prior to
•randomization, IDH mutation testing using sequencing must have been performed
•in subjects <= 55 years of age or in subjects with a history of a low grade
•glioma. In subjects > 55 years of age, a negative immunohistochemistry for the
•IDH R132 mutation is sufficient evidence of an IDH-wild type Glioblastoma.
•- For Part B randomized expansion, MGMT promoter methylation status must be
•available prior to randomization. This is based on evaluation of tumor tissue
•from surgical resection (done locally).
•- Part B expansion, a post-operative baseline contrast-enhanced MRI scan must
•be obtained to be used for stratification of randomization. It is strongly that
•this scan be obtained <72 hours post-surgery (preferably within 24-48 hours
•post-surgery).
•- Karnofsky performance status of >=70 in Part B.
•- Subject must have stable or decreasing dose of steroids at least 1 week prior
•to start of treatment (Day 1). Dose at randomization must be <= 20 mg prednisone
•or <= 3 mg dexamethasone daily (or equivalent).
•- Archival tumor specimens are mandatory in Part B Randomized expansion.
•Inclusion Criteria for both part A and part B
•- Males and females of >= 18 years of age
•- Subject must understand and voluntarily sign an ICF prior to any study-related
•assessments/procedures being conducted.
•- Subject is willing and able to adhere to the study visit schedule and other
•protocol requirements.
•- Subject has newly diagnosed, histologically confirmed WHO Grade IV
•Glioblastoma and must have undergone complete or partial tumor resection.
•- Subject must have recovered from the effects of surgery, including
•post-operative infections or complications.
•- Prior tumor resection up to 8 weeks (preferably within 6 weeks) prior to the
•first dose of CC-90010.
•- Subject with archival tumor tissue suitable for molecular genetic testing
•must give permission to access and test the tissue.
•- Subject must have the normal laboratory values described on the protocol at
•- Females of childbearing potential (FCBP) :
•o Either commit to true abstinence from heterosexual contact (which must be
•reviewed on a monthly basis and source documented) or agree to use, one highly
另有 2 项未显示

排除标准

•Applicable for Part A and Part B:
•1. Prior chemotherapy or other anti-tumor treatment for GBM
•2. Any known metastatic extracranial or leptomeningeal disease.
•3. Secondary GBM
•4. Subjects with indeterminate MGMT promoter methylation status.
•5. Biopsy only of GBM at surgery, defined as < 20% resection of enhancing tumor.
•6. Subject has persistent diarrhea due to a malabsorptive syndrome (such as
•celiac sprue or
•inflammatory bowel disease) NCI CTCAE Grade >= 2, despite medical management, or
•any other significant GI disorder that could affect the absorption of CC-90010.
•7. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal),
•particularly those
•with a history of and/or risk of perforation and GI tract hemorrhages.
•8. Evidence of recent, symptomatic CNS hemorrhage on baseline MRI or CT scan
•CNS hemorrhage of Grade > 1 on baseline MRI scan
•9. Subject who requires increasing doses of corticosteroids to treat
•symptomatic cerebral
•edema within 14 days prior to the first dose of CC-90010.
•10. Known symptomatic acute or chronic pancreatitis.
•11. Impaired cardiac function or clinically significant cardiac diseases as
•defined in the protocol
•12. Pregnant or nursing females.
•13. Known HIV infection.
•14. Known chronic active hepatitis B or C virus (HBV, HCV) infection
•15. Subject with a requirement for ongoing treatment with therapeutic dosing of
•anticoagulants or for ongoing prophylactic anticoagulation.
•16. History of concurrent second cancers requiring active and ongoing systemic
•17. Evidence of history of bleeding diathesis.
•18. Subject with known prior episodes of non-arteritic anterior ischemic optic
•(NAION) should be excluded from the study.
•19. Subject has any significant medical condition in the study or would place
•the subject at unacceptable risk if he/she were to participate in the study.
•20. Subject has any condition that confounds the ability to interpret data from
•21. Subject with poor bone marrow reserve as assessed by Investigator such as
•in conditions
•requiring regular hematopoietic support
•22. Previous SARS-CoV-2 infection
•23. Previous SARS-CoV-2 vaccine within 14 days of C1D1.
•Additional exclusion criteria for Part B:
•- The following therapies are not allowed:
•a. Prior use of Gliadel wafers or any other intratumoral or intracavitary
•b. Planned additional treatment with Tumor-treating Fields.
•- Any known metastatic extracranial or leptomeningeal disease.
•- Secondary GBM (ie, progression from prior low-grade or anaplastic glioma)
•- Subjects with indeterminate MGMT promoter methylation status in Part B.
•- Biopsy only of GBM at surgery, defined as < 20% resection of enhancing tumor.
•- Evidence of recent, symptomatic CNS hemorrhage on baseline MRI or CT scan
•and/or CNS hemorrhage of Grade > 1 on baseline MRI scan, unless subsequently
•documented to have resolved.

研究者

发起方

Celgene Corporation

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