NO_LONGER_AVAILABLENot Applicable

Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

United States

Plain-language summary

An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Total bilirubin ≤ 2.0 times upper limit of normal (ULN). Total bilirubin must be \< 3 X ULN for patients with Gilbert's syndrome.
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 X ULN (if liver metastases are present, then ≤ 5 X ULN is allowed).
✓. Serum creatinine ≤ 1.5 X ULN.
✓. Neutrophil absolute count ≥ 1,500/mm3 (≥1.5 X 109/L).
✓. Platelet count ≥ 75,000/mm3 (≥100 X 109/L).
✓. Hemoglobin ≥ 9g/dL (transfusion within 30 days of screening is permitted).

✕. Pulmonary embolism within 28 days before first dose of study drug.
✕. Any history of acute myocardial infarction within 6 months before first dose of study drug.
✕. Uncontrolled hypertension that cannot be managed by standard anti-hypertension medications within 28 days before first dose of study drug.

NCT IDNCT04681248

SponsorLeap Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS