A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 11
- 试验地点
- 9
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
详细描述
This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with non-small cell lung, pancreatic or colorectal cancer and cachexia feel after receiving repeated subcutaneous dosing. During the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. There is a 12-week follow-up period following the last dose of study drug. Additional assessments include:
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body weight measurements
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blood pressure and heart rate measurements
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Lumbar Skeletal Muscle Index (LSMI) by CT scan
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Blood samples:
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to evaluate safety,
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to measure the amount of the study drug in the blood,
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to evaluate if the study drug causes an immune response,
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to examine the effects of the study drug on levels of a specific cytokine,
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and for exploratory samples for bio banking.
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Measure the impact of the study drug on appetite, nausea, vomiting, fatigue, physical function, and health-related quality of life with questionnaires.
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Measure the impact of study drug on physical activity using wearable digital sensors.
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To evaluate the effect of study drug on ability to complete anti-tumor treatment and survival in participants with cancer and cachexia.
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To evaluate tumor size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
- •Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.;
- •Will receive the following for non-small cell lung cancer:
- •a platinum + pemetrexed ± pembrolizumab or
- •a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or
- •pembrolizumab alone
- •Will receive the following for pancreatic cancer:
- •FOLFIRINOX or
- •Nab-Paclitaxel + Gemcitabine
- •Gemcitabine
- •Will receive the following for colorectal cancer:
- •FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
- •FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
- •FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
- •Pembrolizumab for MSI-H • Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy.
- •Adequate renal and liver function.
- •Signed informed consent.
排除标准
- •All other forms of cancers not specified above unless currently considered cured (>5 years without evidence of recurrence).
- •Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted
- •Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS.
- •known symptomatic brain metastases requiring steroids.
- •Active hepatitis B or C virus.
- •Confirmed positive HIV test.
- •Current active reversible causes of decreased food intake.
- •Receiving tube feedings or parenteral nutrition at Screening.
- •Elevated blood pressure that cannot be controlled by medications.
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
PF-06946860
subcutaneous injection
干预措施: PF-06946860 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From Day 1 up to Week 24
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Number of Participants With Post-Baseline Vital Signs Abnormalities
时间窗: From Day 1 up to Week 24
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
时间窗: From Day 1 up to Week 24
Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for urinalysis, Urine Glucose ≥1, Ketones ≥1, Urine Protein ≥1, Urine Hemoglobin ≥1, Urobilinogen ≥1, Nitrite ≥1, and Leukocyte ≥1 Esterase ≥1; Hyaline Casts \>1/LPF.
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
时间窗: From Day 1 up to Week 24
ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec.
次要结局
- Serum Total Ctrough of PF-06946860(Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15)
- Serum Unbound Trough Concentrations (Ctrough) of PF-06946860(Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15)