Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: ALD518: Group A: ALD518 80 mg every 8 weeks (3 doses)
Group B: ALD518 160 mg every 8 weeks (3 doses)
Group C: ALD518 320 mg every 8 weeks (3 doses)
Control Intervention1: Placebo: Grou
Sponsors
Alder Biopharmaceuticals Inc
Veeda Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of NSCLC incurable by other treatments including surgery 2. Eastern Cooperative Oncology Group2 (ECOG) performance status: 0-3 3. Able to fulfill International Classification of Diseases-10 (ICD-10) criteria for cancer?related fatigue. 4. Have experienced ≥ 5% loss of body weight in the preceding 3 months 5. Have a plasma C-reactive protein (CRP) concentration ≥ 10mg/L 6. Have a life expectancy of at least 12 weeks 7. Able to comply with the protocol 8. Able to understand the information provided to them and to give written informed consent 9. Aged ≥ 18 years of age 10. 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-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. 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. 2. Have serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of &#8805; 3 x the upper limit of normal (ULN) at Screening. 3. Have hemoglobin < 8 g/dL at Screening 4. Have neutrophil count < 1.5 x 109/L at Screening 5. Have platelet count < 75 x 109/L at Screening 6. Have had chemotherapy, large field radiotherapy, or surgery for the treatment of their cancer within 30 days before dosing in the study 7. Have planned chemotherapy, large field radiotherapy, or surgery for the treatment of their cancer during the study 8. Diagnosed with any unstable, uncontrolled brain metastases 9. Have a previous history of tuberculosis 10. Have active tuberculosis infection 11. Have a current serious infection (requiring treatment with parenteral antibiotics) 12. Have a history of hypersensitivity to monoclonal antibodies 13. Have current habitual drug abuse including alcohol 14. 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 15. Have received monoclonal antibody treatment within 6 months of Screening (within or outside a clinical study) 16. Regularly take high dose corticosteroids or progestogens for purposes other than hormone replacement therapy) (>7.5 mg prednisolone or equivalent) per day 17. Are likely to require treatment during the study with drugs not permitted by the study protocol 18. 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) 19. 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. 20. Are pregnant or a nursing mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is change in safety as follows: 1. Incidence and severity of AEs and SAEs during the study 2. Changes in vital signs and 12-lead ECG during the study 3. Changes in physical examination during the study 4. Changes in laboratory assessments (serum chemistry, hematology, and urinalysis) during the study. Timepoint: Day-1, week-2, week-4, week-8, week-16, week-20, week-24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to symptomatic progression (Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F), at Weeks 12 and 24 Secondary efficacy endpoints are: 2. Changes from baseline in FACIT-F, at each visit 3. Changes from baseline in Functional Assessment of Anorexia/Cachexia Therapy (FAACT), at each visit 4. Changes from baseline in Functional Assessment of Cancer Therapy-Lung (FACT-L), at each visit 5. Changes from baseline in Short Form-36 (SF-36), at each visit 6. Changes from baseline in hand grip strength, at each visit 7. 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 peak concentration (Tmax), area under the concentration-time curve extrapolated to infinity (AUC&#8734;), and elimination half life (t½) 10. The evaluation of pharmacodynamic parameters over time: concentrations of CRP and D-dimer. 11. Evaluation of immunogenicity anti-ALD518. Timepoint: day-1, week-2, week-4, week-8, week-12, week-16, week-20, week-24 | — |
Countries
India
Contacts
Public ContactVivek Sood
Outcome results
None listed