A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO ASSESS THE EFFECT OF REPEATED SUBCUTANEOUS ADMINISTRATION OF PF-06946860 ON APPETITE IN PARTICIPANTS WITH ADVANCED CANCER AND ANOREXIA, FOLLOWED BY AN 18-WEEK OPEN-LABEL TREATMENT PERIOD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 33
- 主要终点
- Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
研究概览
简要总结
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.
详细描述
A 6 week double blind study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously).
During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo.
Assessments include:
- Measure the impact of the study drug on appetite, fatigue, and pain questionnaires
- Body weight measurements
- Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
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
- •Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced.
- •Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
- •Meets any of the following criteria at Randomization:
- •Not currently receiving antineoplastic therapy
- •On standard of care systemic antineoplastic therapy or treatment without curative intent
- •Signed informed consent.
排除标准
- •Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
- •Current active reversible causes of decreased food intake.
- •Current, severe gastrointestinal disease
- •Participants with known symptomatic brain metastases requiring steroids.
- •Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness
- •inadequate renal or liver function.
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
subcutaneous injection
干预措施: PF-06946860 (Drug)
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
subcutaneous injection
干预措施: PF-06946860 (Drug)
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
subcutaneous injection
干预措施: Placebo for PF-06946860 (Drug)
结局指标
主要结局
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
时间窗: Baseline, Week 4
The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.
次要结局
- Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A(Day 1 through Week 6 (for a period of 6 weeks))
- Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A(Baseline, Weeks 1, 2, 3, 5 and 6)
- Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A(Baseline, Weeks 1, 2, 3, 4, 5 and 6)
- Number of Participants With Laboratory Test Abnormalities in Part A(Days 1, 22 and 43)