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Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients

StatusActive, Not Recruiting
PhasePhase 3
Started2022-01-03
View on ClinicalTrials.gov ↗

Amendment history

2026-07-29
Study Status v29
Primary completion moved earlier: 2027-04-01 → 2026-04-14
Completion moved earlier: 2027-12-31 → 2026-12-31
2026-04-09
Study Status, Study Design, Contacts/Locations v28
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 360 → 227 participants
Study sitesdetails revised at 293 of 293 sites
2026-03-02
Study Status, Contacts/Locations v27
Study sitesdetails revised at 7 of 293 sites
2026-02-09
Study Status v26
Primary completion date2026-04-01→2027-04-01
Completion date2026-12-31→2027-12-31
2026-02-03
Study Status, Contacts/Locations v25
Study sitesdetails revised at 8 of 293 sites
Show 24 earlier versions
2026-01-06
Study Status, Contacts/Locations v24
Study sitesdetails revised at 6 of 293 sites
2025-11-04
Study Status, Contacts/Locations v23
Study sites290→293
2025-10-07
Study Status, Contacts/Locations v22
Study sitesdetails revised at 11 of 290 sites
2025-09-05
Study Status, Contacts/Locations v21
Study sites284→290
2025-06-24
Study Status, Contacts/Locations v20
Study sites272→284
2025-06-18
Study Status v19
Primary completion date2026-05-01→2026-04-01
Completion date2026-12→2026-12-31
2025-03-28
Study Status, Oversight, Contacts/Locations v18
Study sites261→272
2025-01-15
Study Status, Oversight, Contacts/Locations v17
Study sitesdetails revised at 220 of 261 sites
2024-12-24
Study Status, Contacts/Locations v16
Study sites252→261
2024-10-24
Study Status, Contacts/Locations v15
Study sites249→252
2024-08-01
Study Status, Contacts/Locations v14
Study sites246→249
2024-05-22
Study Status, Contacts/Locations v13
Primary completion date2024-04-01→2026-05-01
Completion date2024-12→2026-12
Study sites231→246
2024-04-08
Study Status, Contacts/Locations v12
Start date2021-10-15→2022-01-03
Study sites214→231
2024-02-19
Study Status, Contacts/Locations v11
Study sites197→214
2023-10-30
Study Status, Contacts/Locations v10
Study sites177→197
2023-07-19
Study Status, Contacts/Locations v9
Study sites175→177
2023-05-11
Study Status, Contacts/Locations v8
Study sites68→175
2023-03-29
Study Status, Eligibility v7
Eligibility criteria-1 characters
[...] se (ALT) =< 3 x upper limit of normal (ULN) Fasting glucose >< 1410140 mg/dldL Granulocytes > 1000/hpf No treatment with another antipsych [...]
2023-03-23
Study Status v6
Primary completion date2023-04-01→2024-04-01
Completion date2023-12→2024-12
2022-01-11
Study Status, Contacts/Locations v5
Study sites43→68
2021-12-13
Study Status, Contacts/Locations v4
Study sites20→43
2021-11-11
Study Status, Contacts/Locations v3
Study sites6→20
2021-11-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-10→confirmed 2021-10-15
Study sites0→6
2021-10-14
Study Status, Eligibility v1
Eligibility criteria+66 characters
[...] these patients may have difficulty taking oral medications No history of hypersensitivity to olanzapine or megestrol acetate No COVID-19 infection in the past that, in the opinion of th [...]
2021-06-17
Original filing
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
Trial Details
NCT Number NCT04939090
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Malignant Solid Neoplasm, Anorexia, Hematopoietic and Lymphoid Cell Neoplasm
Enrollment 227 participants
Start Date 2022-01-03
Primary Completion 2026-04-14 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30