A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors and Tenosynovial Giant Cell Tumor - Advanced Tumors and Tenosynovial Giant Cell Tumor

Deciphera Pharmaceuticals LLC0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Deciphera Pharmaceuticals LLC
入组人数: 10

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

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研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Inclusion Criteria (Dose Escalation Phase)
•Patients must meet all of the following criteria to be eligible to enroll in
•the Dose Escalation phase of the study:
•1) Male or female patients >=18 years of age
•2) Any of the following solid tumors:
•a) Advanced MST that has progressed after treatment with all available
•therapies known to confer clinical benefit or for
•which conventional therapy is not considered effective as judged by the
•Investigator:
•i) Solid tumors, including but not limited to, metastatic breast or prostate
•cancer with bone disease
•ii) Solid tumors including, but not limited to, gastric, ovarian or non-small
•cell lung cancer (NSCLC) that frequently
•have malignant associated ascites or effusion(s)
•iii) Tumors with known contribution of macrophages or phagocytes such as but
•not limited to:
•(1) Tumors with high tumor-infiltrating macrophage content
•(2) Tumor types with high expression of the receptor CSF1R or its ligands, CSF1
•or IL-34, in the tumor by previous testing
•(3) Prostate or breast cancer with bone-only disease
•iv) NSCLC patients with:
•(1) Histologically or cytologically confirmed metastatic, or unresectable
•locally advanced, recurrent NSCLC with a known epidermal growth factor receptor
•(EGFR) mutation(s)
•(2) Documented disease progression while on a previous treatment with an EGFR
•tyrosine kinase inhibitor
•b) TGCT patients: Histologically confirmed diagnosis of TGCT (formerly known as
•pigmented villonodular synovitis or giant cell tumor of the tendon sheath).
•Tumor biopsy to confirm
•TGCT diagnosis will be required if no histology/pathology is available at the
•time of screening
•i) Disease for which surgical resection will potentially cause worsening
•functional limitation or severe morbidity as judged by the Investigator
•ii) Symptomatic disease with at least moderate pain or stiffness (a score of 4
•or more with 10 describing the worst condition) within 1 month of the first
•dose documented in the medical record
•iii) Prior treatment with anti-CSF1 or anti-CSF1R therapy is allowed
•(1) Exception 1: discontinuation of anti-CSF1 or anti-CSF1R due to drug-induced
•liver injury
•3) MST patients only: Able to provide a tumor tissue sample; if an
•archival tumor tissue sample is unavailable, patients must be willing to
•undergo a tumor biopsy prior to the first dose of study drug, if the tumor is
•accessible to biopsy and, in the judgment of
•the Investigator, the tumor biopsy will be done safely
•4) Patients must have at least 1 measurable lesion according to RECIST Version
•1.1 (non-nodal lesions must be >=1.0 cm in the long axis or >=double the slice
•thickness in the long axis; nodal lesions must be >=1.5 cm in the short axis)
•except for prostate or breast cancer patients with bone-only disease
•a) A lesion in a previously irradiated area is eligible to be considered as
•measurable disease as long as there is objective evidence of progression of the
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排除标准

•Exclusion Criteria (Dose Escalation Phase)
•Patients meeting any of the following criteria will be excluded from the
•Dose Escalation phase of the study:
•1. Treatment with anticancer therapy, therapy for TGCT, including
•investigational therapy, within 2 weeks prior to the administration of study
•drug. For immediately prior therapies with a half-life (t1/2) longer than 3
•days, or if the t1/2 is not available, the interval must be >=28 days prior to
•the first administration of study drug
•2. Unresolved toxicity according to NCI-CTCAE, Version 4.03 (ie, Grade >1 or
•baseline) from previous anticancer or TGCT therapy, excluding alopecia
•3. The patient has known active central nervous system (CNS) metastases.
•Patients with previously treated brain metastases may participate provided
•a. They are stable (ie, no evidence of progression by magnetic resonance
•imaging [MRI]) for at least 4 weeks prior to the first dose of study drug),
•b. All neurologic symptoms have returned to baseline, and
•c. Patients do not require continued steroid therapy or use of enzyme-inducing
•antiepileptic drugs. Patients can be switched to a non-enzyme inducing
•antiepileptic drug. If signs or symptoms suggest CNS metastases, a brain
•MRI/computed tomography (CT) scan must be performed to confirm absence of
•detectable CNS disease within 2 weeks prior to receiving study drug.
•4. New York Heart Association class III or IV heart disease, active ischemia
•or any other uncontrolled cardiac condition such as angina pectoris, clinically
•significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or
•congestive heart failure
•5. Systemic arterial thrombotic or embolic events, such as cerebrovascular
•accident (including ischemic attacks) or hemoptysis within 6 months prior to
•the start of study drug
•6. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary
•arterial events (eg, pulmonary embolism) within the 1 month prior to the start
•of study drug
•7. Baseline prolongation of the QTcF based on repeated demonstration of QTcF
•>450 ms in males or >470 ms in females or history of long QT syndrome
•8. LVEF <50%
•9. Concurrent treatment with prohibited medications
•10. Major surgery within 2 weeks of the first dose of study drug; following
•major surgeries >2 weeks prior to the first dose of study drug, all surgical
•wounds must be healed and free of infection or dehiscence
•11. Any other clinically significant comorbidities, such as significant
•concomitant arthropathy in the affected joint, or any other serious medical or
•psychiatric condition(s), known current alcohol abuse, which in the judgment of
•the Investigator, could compromise compliance with the protocol, interfere with
•the interpretation of study results, or predispose the patient to safety risks
•12. Malabsorption syndrome or other illness that could affect oral absorption
•as judged by the Investigator
•13. Known human immunodeficiency virus, active hepatitis B, active hepatitis
•C, or active mycobacterium tuberculosis infection
•14. If female, the patient is pregnant or lactating
•15. Known allergy or hypersensitivity to any component of the study drug
•Exclusion Criteria (Expansion Phase, TGCT Patients)
•Patients meeting any of the following criteria will be excluded from the
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研究者

发起方

Deciphera Pharmaceuticals LLC

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