跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT00953758
NCT00953758已完成1 期

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS SINGLE AGENT IN SELECT HEMATOLOGIC MALIGNANCIES

Pfizer6 个研究点 分布在 2 个国家目标入组 47 人开始时间: 2010年3月3日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
Pfizer
入组人数
47
试验地点
6
主要终点
Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. They may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response.
  • •ECOG performance status 0 to 2
  • •Adequate organ function

排除标准

  • •Patients with active CNS disease
  • •Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer
  • •Active GVHD other than Grade 1 skin involvement
  • •Known malabsorption syndrome
  • •Patient has an active, life threatening or clinically significant uncontrolled systemic infection

研究组 & 干预措施

1

Experimental

干预措施: PF-04449913 (Drug)

结局指标

主要结局

Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)

时间窗: Cycle 1 Day 1 to end of Cycle 1 (28 days)

Any DLT event in Cycle 1: 1) Grade \>=3 non-hematologic toxicity that had been maximally treated, 2) prolonged myelosupression that lasted greater than (\>) 42 days from the point of detection in a normal bone marrow (less than \[\<\] 500 per microliter \[/uL\] or platelet count \<10,000/uL, or hemoglobin \<8 gram per deciliter \[g/dL\] with \<5% blasts and no evidence of disease or dysplasia), 3) inability to deliver \>= 80% of the planned doses due to PF-04449913 related non-hematologic and hematologic toxicities

次要结局

  • Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21(Baseline, Cycle 1 Day 21)
  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade(Baseline up to 28 days post last dose of study medication (maximum duration: 537 days))
  • Maximum Observed Plasma Concentration (Cmax) on Lead-in(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6))
  • Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade(Baseline up to 28 days post last dose of study medication (maximum duration: 537 days))
  • Apparent Oral Clearance (CL/F) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Apparent Volume of Distribution (Vz/F) on Lead-in(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6))
  • Plasma Decay Half-life (t1/2) on Lead-in(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6))
  • Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUCinf) on Lead-in(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6))
  • Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria(Screening up to maximum of 537 days)
  • Number of Participants With Laboratory Test Abnormalities(Screening to EOT (maximum duration: 537 days))
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6))
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Apparent Oral Clearance (CL/F) on Lead-in(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6))
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Average Plasma Concentration (Cavg) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Minimum Plasma Concentration (Cmin) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Pre-dose Concentration (Ctrough) on Cycle 1 Day 21(Pre-dose on Cycle 1 Day 21)
  • Accumulation Ratio (Rac)(Pre-dose, 1 hour post-dose on Cycle 1 Day 1; Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21)
  • Linearity Ratio (Rss)(Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose during the lead-in period (Day -6); Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21)
  • Renal Clearance on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Amount of Unchanged Drug Excreted in Urine (Over the Dosing Interval) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Percentage of Dose Excreted Unchanged in Urine (Over the Dosing Interval) on Cycle 1 Day 21(Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21)
  • Percentage of Participants With Objective Response (OR)(Baseline to end of study (up to 537 days))
  • Time to Progression (TTP)(Baseline to end of study, up to 36 months)
  • Duration of Response (DR)(Baseline to end of study, up to 36 months)
  • Progression-Free Survival (PFS)(Baseline to end of study, up to 36 months)
  • Number of Participants With Increase From Baseline in Corrected QT Interval Using Fridericia's Formula (QTcF)(Screening; predose, 1, 4, 24 hours (hr) postdose on Day -6; predose, 1 hr postdose on Cycle 1 Day 1; 1 hr postdose on Cycle 1 Days 8, 15; Day 1 of every subsequent cycle; predose, 1, 2, 4, 24 hr postdose for Cycle 1 Day 21; EOT (max reached: Cycle 20))
  • Number of Participants With Decrease From Baseline in QTcF Interval(Baseline up to maximum of 537 days)
  • Number of Participants With Post-baseline QTcF Interval >= 500 Msec(Baseline up to maximum of 537 days)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验

已完成
1 期
A Study Of PF-04449913 Administered Alone In Select Solid TumorsSolid Tumors
NCT01286467Pfizer23
已完成
1 期
A Phase I Study of the Chimeric Anti-CD40 Monoclonal Antibody ChiLob 7/4 to Treat Advanced Malignancies Refractory to Conventional Anti-cancer TreatmentNeoplasmsNon-HodgkinB-CellCancerLymphoma
NCT01561911Cancer Research UK29
终止
1 期
Vaccine-Based Immunotherapy Regimen For NSCLC and TNBCNon-Small Cell Lung CancerTriple-negative Breast Cancer
NCT03674827Pfizer36
撤回
1 期
Phase 1 Single Subcutaneous Dose Study of MLN1202Healthy Japanese and Caucasian Male Adults
NCT02426021Takeda
招募中
1 期
Study of SYN818 for the Treatment of Advanced or Metastatic Solid TumorsAdvanced Solid CancerMetastatic Solid TumorOvarian CancerBRCA MutationHRR DeficiencyProstate CancerBreast Cancer
NCT06666270Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd30