2024-514933-39-00招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Safety: DLTs, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose reduction or discontinuation of study drug due to toxicity, physical examination findings, ECOG PS, changes from baseline in laboratory parameters, electrocardiograms (ECGs), LVEF, and vital signs.
研究概览
简要总结
- To assess the safety and tolerability of DCC-3014
- To characterize the pharmacokinetic (PK) profile of DCC-3014
- To determine the maximum tolerated dose (MTD) of DCC-3014
- To determine the recommended Phase 2 dose (RP2D) of DCC-3014
- To evaluate antitumor activity of DCC-3014 using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in tenosynovial giant cell tumor (TGCT; formerly known as pigmented villonodular synovitis [PVNS or giant cell tumor of the tendon sheath [GCT-TS]) (Expansion Cohort A only)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Expansion Phase Cohort B
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients ≥18 years of age
- •Must be able to take oral medication
- •Patients of reproductive potential must: a. Have a negative serum β-hCG pregnancy test at screening for female patients, and b. Agree to follow the contraception requirements
- •The patient is capable of understanding and complying with the protocol and has signed the ICF. A signed ICF must be obtained before any study-specific procedures are performed
- •Must be willing and able to complete PRO assessments on an electronic device
- •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
- •Disease for which surgical resection will potentially cause worsening functional limitation or severe morbidity as determined by surgical consultation or a multidisciplinary tumor board
- •Symptomatic disease with at least moderate pain per BPI Worst Pain or at least moderate stiffness per Worst Stiffness numeric rating scale (NRS) item (defined as a score of 4 or more, with 10 describing the worst condition) within 30 days of the first dose documented in the medical record
- •Patient should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements outlined in Table 7
- •An analgesic regimen, if used, needs to be stable as judged by the Investigator for at least 2 weeks prior to Cycle 1 Day 1
- •Expansion Cohort B: prior systemic treatment with anti-CSF1 or antiCSF1R therapy, with the exception of imatinib or nilotinib
- •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). 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 lesion before study enrollment
- •Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed within 21 days prior to the first dose of study drug: a. Bone marrow function: ANC ≥1500/μL; hemoglobin ≥10 g/dL; platelet count ≥lower level of normal b. Hepatic function: Total serum bilirubin ≤ULN; serum AST/ALT ≤ULN c. Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥ 50 mL/min based either on urine collection or Cockcroft-Gault estimation
排除标准
- •Expansion Cohort A: previous use of systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed
- •Concurrent treatment with prohibited medications
- •Major surgery within 14 days of the first dose of study drug; following major surgeries >14 days prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence
- •Any 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
- •Malabsorption syndrome or other illness that could affect oral absorption as judged by the Investigator
- •Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection
- •If female, the patient is pregnant or lactating
- •Known allergy or hypersensitivity to any component of the study drug
- •Contraindication to MRI
- •Active liver or biliary disease including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis
- •Expansion Cohort B: discontinuation of anti-CSF1 or anti-CSF1R due to drug-induced liver injury
- •Treatment with therapy for TGCT, including investigational therapy, within 14 days prior to the administration of study drug. For immediately prior therapies with a 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
- •Known metastatic TGCT or other active cancer that requires concurrent treatment
- •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
- •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
- •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
- •Baseline prolongation of QTcF based on repeated demonstration of QTcF >450 ms in males or >470 ms in females or history of long QT syndrome
结局指标
主要结局
Safety: DLTs, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose reduction or discontinuation of study drug due to toxicity, physical examination findings, ECOG PS, changes from baseline in laboratory parameters, electrocardiograms (ECGs), LVEF, and vital signs.
Safety: DLTs, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose reduction or discontinuation of study drug due to toxicity, physical examination findings, ECOG PS, changes from baseline in laboratory parameters, electrocardiograms (ECGs), LVEF, and vital signs.
Pharmacokinetics: The following PK endpoints, including but not limited to, will be evaluated for both DCC-3014 parent and its metabolite, DP-7005, if detected: • Time to maximum observed concentration (Tmax) • Maximum observed concentration (Cmax) • Trough observed concentration (Cmin) • Area under the concentration-time curve (AUC) • t1/2
Pharmacokinetics: The following PK endpoints, including but not limited to, will be evaluated for both DCC-3014 parent and its metabolite, DP-7005, if detected: • Time to maximum observed concentration (Tmax) • Maximum observed concentration (Cmax) • Trough observed concentration (Cmin) • Area under the concentration-time curve (AUC) • t1/2
Efficacy (TGCT Expansion Cohort A only): • Objective response rate (ORR=complete response [CR]+partial response [PR]) assessed by independent radiological review using RECIST Version 1.1 at Week 25 (Cycle 7 Day 1) • Duration of Response (DOR; time from PR or CR to disease progression or death)
Efficacy (TGCT Expansion Cohort A only): • Objective response rate (ORR=complete response [CR]+partial response [PR]) assessed by independent radiological review using RECIST Version 1.1 at Week 25 (Cycle 7 Day 1) • Duration of Response (DOR; time from PR or CR to disease progression or death)
次要结局
- ORR assessed by independent radiological review using TVS and mRECIST (TGCT Expansion Cohort A only)
- ROM: change from baseline to Week 25 (Cycle 7 Day 1) (TGCT Expansion Cohort A only)
- Response based on BPI worst pain NRS and narcotic analgesic use by Brief Pain Inventory-30 (BPI-30) at Week 25 (Cycle 7 Day 1) (TGCT Expansion Cohort A only)
- PRO based upon the PROMIS physical function questionnaire and worst stiffness NRS: Change from starting value to Week 25 (Cycle 7 Day 1) (TGCT Expansion Cohort A only)
研究者
Clinical trial information
Scientific
Deciphera Pharmaceuticals Inc.
研究点 (9)
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