Solid tumors
Conditions
Interventions
KP-483 is given orally once daily in the morning. Administration will continue until intolerable toxicity occurs or disease progression is observed.
Sponsors
Doi Toshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed diagnosis of advanced or recurrent solid tumors 2. Patients whose cancer progressed after standard treatment or for whom no appropriate standard treatment is available 3. Patients whose Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) was 0 or 1 in the 14 days before enrollment 4. Patients with a life expectancy of 90 or more days at the time of enrollment
Exclusion criteria
Exclusion criteria: 1. Patients who have symptomatic or treatment-requiring central nervous system metastasis. However, those who don't take any anti-convulsant and have not been treated with corticosteroids for the central nervous system metastasis in the 14 days beforethe enrollment are eligible. 2. Patients with multiple primary cancers. However, patients whose other cancer does not require treatment are eligible. 3. Patients who have received any of the following anti-cancer treatments: - Patients who have received radiotherapy in the 28 days before enrollment. Regarding radiotherapy for pain relief, patients who have received radiotherapy in the 14 days before enrollment. - Patients who have received other anti-cancer drugs (including hydroxyurea) in the 14 days before enrollment. Regarding antibody drugs and immune checkpoint inhibitors, patients who have received such drugs in the 28 days before enrollment. - Patients who have received other study drugs in the 28 days before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity | — |
Contacts
Public ContactContact for Clinical Trial
KAKEN PHARMACEUTICAL CO., LTD.
Outcome results
None listed