A phase II study to determine the safety, efficacy, and pharmacokinetics of multiple intravenous doses of ald518 80 mg, 160 mg, and 320 mg versus placebo administered to patients with non-small cell lung cancer-related fatigue and cachexia.

Alder Biopharmaceuticals Inc13 个研究点分布在 1 个国家目标入组 0 人开始时间: 待定

试验速览

阶段: 2 期
发起方
试验地点: 13
主要终点: Primary endpoint is change in safety as follows:1. Incidence and severity of AEs and SAEs during the study2. Changes in vital signs and 12-lead ECG during the study3. Changes in physical examination during the study4. Changes in laboratory assessments (serum chemistry, hematology, and urinalysis)during the study.

研究概览研究设计入排标准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 is a phase II study to determine the safety, efficacy, and pharmacokinetics of multiple intravenous doses of ald518 80 mg, 160 mg, and 320 mg versus placebo administered to patients with non-small cell lung cancer-related fatigue and cachexia. This will be carried out in countries like Russia, Georgia, Australia, New Zealand, Romania, Poland, Serbia, Canada and India, In India it will be done in total 13 centres. A total of 120 patients are to be enrolled in the trial. We are expecting about 50 patients to be enrolled from India. The Primary safety parameters are Vital signs, physical examination, 12-lead electrocardiogram (ECG), adverseevents (AEs), serum chemistry, hematology, and urinalysis.The efficacy parameter are Symptomatic progression, Functional Assessment of Cancer Therapy-Lung(FACT-L), Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F), Functional Assessment of Anorexia/Cachexia Therapy(FAACT), Short Form-36 (SF-36), hand grip strength, lean body mass, and time to death (survival).

研究设计

分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

入选标准

•Confirmed diagnosis of NSCLC incurable by other treatments including surgery
•Eastern Cooperative Oncology Group2 (ECOG) performance status: 0-
•Able to fulfill International Classification of Diseases-10 (ICD-10) criteria for cancer?related fatigue.
•Have experienced ≥ 5% loss of body weight in the preceding 3 months
•Have a plasma C-reactive protein (CRP) concentration ≥ 10mg/L
•Have a life expectancy of at least 12 weeks
•Able to comply with the protocol
•Able to understand the information provided to them and to give written informed consent
•Aged ≥ 18 years of age
•Are not pregnant and do not plan to become pregnant during the study.Females with childbearing potential must provide a negative pregnancy test within the Screening period (Day -35 to -7) and must be using adequate contraception (oral or injectable [depot] oestrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method[e.g., condom and diaphragm or spermicidal gel]).
•Non-childbearingpotential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start.

排除标准

•Exclusion Criteria:
•Have any past or current, acute or chronic concurrent medical condition/illness that the investigator or designated physician feels will compromise patient safety or any other aspects of the study.
•Have serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of ≥ 3 x the upper limit of normal (ULN) at Screening.
•Have hemoglobin < 8 g/dL at Screening
•Have neutrophil count < 1.5 x 109/L at Screening
•Have platelet count < 75 x 109/L at Screening
•Have had chemotherapy, large field radiotherapy, or surgery for the treatment of their cancer within 30 days before dosing in the study
•Have planned chemotherapy, large field radiotherapy, or surgery for the treatment of their cancer during the study
•Diagnosed with any unstable, uncontrolled brain metastases
•Have a previous history of tuberculosis
•Have active tuberculosis infection
•Have a current serious infection (requiring treatment with parenteral antibiotics)
•Have a history of hypersensitivity to monoclonal antibodies
•Have current habitual drug abuse including alcohol
•Have received any experimental, unregistered therapy (within or outside a clinical study) within 30 days or five plasma half-lives (which ever is shorter) before dosing
•Have received monoclonal antibody treatment within 6 months of Screening (within or outside a clinical study)
•Regularly take high dose corticosteroids or progestogens for purposes other than hormone replacement therapy) (>7.5 mg prednisolone or equivalent) per day
•Are likely to require treatment during the study with drugs not permitted by the study protocol
•Are participating in (or planning to participate in) any other clinical study during the study (Patient may be followed for survival if they have completed or withdrawn from a previous study)
•Have any physical disability (e.g., amputation of a limb) which would interfere with completion of the hand grip strength measurement or any other protocol-related procedure.
•Are pregnant or a nursing mother.

结局指标

主要结局

Primary endpoint is change in safety as follows:1. Incidence and severity of AEs and SAEs during the study2. Changes in vital signs and 12-lead ECG during the study3. Changes in physical examination during the study4. Changes in laboratory assessments (serum chemistry, hematology, and urinalysis)during the study.

时间窗: Day-1, week-2, week-4, week-8, week-16, week-20, week-24

次要结局

1. Time to symptomatic progression (Functional Assessment of Chronic IllnessTherapy-Fatigue; FACIT-F), at Weeks 12 and 24Secondary efficacy endpoints are:2. Changes from baseline in FACIT-F, at each visit3. Changes from baseline in Functional Assessment of Anorexia/Cachexia Therapy(FAACT), at each visit4. Changes from baseline in Functional Assessment of Cancer Therapy-Lung(FACT-L), at each visit5. Changes from baseline in Short Form-36 (SF-36), at each visit6. Changes from baseline in hand grip strength, at each visit7. Changes from baseline in weight and lean body mass, at each visit.8. Time to death (survival) will be evaluated during the study.9. The evaluation of PK over time: peak plasma concentration (Cmax), time to peakconcentration (Tmax), area under the concentration-time curve extrapolated to infinity(AUC∞), and elimination half life (t½)10. The evaluation of pharmacodynamic parameters over time: concentrations of CRPand D-dimer.11. Evaluation of immunogenicity anti-ALD518.(day-1, week-2, week-4, week-8, week-12, week-16, week-20, week-24)

研究者

发起方

Alder Biopharmaceuticals Inc

申办方类型

Pharmaceutical industry-Global

研究点 (13)

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