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US 2025/0017931 A1Published application
Methods of personalizing cancer treatment
AssigneeProcessa Pharmaceuticals, Inc.,
InventorsDavid YOUNG, Sian BIGORA, Lorenzo LEONI, Khalid ISLAM
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Abstract
The present disclosure provides, among other things, personalized methods of administering PCS6422 and capecitabine in combination, personalized methods of cancer treatment, and methods of determining the frequency of (i) PCS6422 and capecitabine or (ii) capecitabine administration in a subject.
Claims11
A method of determining frequency of PCS6422 and capecitabine administration to a subject comprising:
- (i) administering at least one dose of an effective amount of PCS6422 to the subject;
- (ii) about 12 to about 24 hours after administering the at least one dose of the effective amount of PCS6422, administering at least one dose of a therapeutically effective amount of capecitabine to the subject
- wherein a blood sample obtained from the subject was measured for α-fluoro-β-alanine (FBAL) and 5-fluorouracil (5-FU);
- (iii) determining one or more of the measured 5-FU, the measured FBAL, and/or a ratio of measured FBAL to measured 5-FU (FBAL:
- 5-FU ratio);
- and
- (iv) after a drug-free period, repeating steps (i) and (ii) when at least one of the following conditions are met:
- the measured 5-FU was less than a certain 5-FU threshold, the measured FBAL is greater than or equal to a certain FBAL threshold, the FBAL:
- 5-FU ratio determined was greater than or equal to a certain FBAL:
- 5-FU ratio threshold, the measured 5-FU is zero, or the measured FBAL is zero.
7 more elements
A method of determining frequency of capecitabine administration to a subject comprising:
- (i) administering at least one dose of an effective amount of PCS6422 to the subject;
- (ii) about 12 to about 24 hours after administering the at least one dose of the effective amount of PCS6422, administering at least one dose of a therapeutically effective amount of capecitabine to the subject, wherein a blood sample obtained from the subject was measured for α-fluoro-β-alanine (FBAL) and/or 5-fluorouracil (5-FU);
- (iii) determining one or more of the measured 5-FU, the measured FBAL, or a ratio of measured FBAL to measured 5-FU (FBAL:
- 5-FU ratio);
- and
- (iv) stopping administering an additional dose of the therapeutically effective amount of capecitabine to the subject when the measured 5-FU was less than a certain 5-FU threshold, the measured FBAL is greater than or equal to a certain FBAL threshold, or the FBAL:
- 5-FU ratio determined was greater than or equal to a certain FBAL:
- 5-FU ratio threshold.
5 more elements
A method of treating cancer in a subject in need thereof comprising:
- (i) administering at least one dose of an effective amount of PCS6422 to the subject;
- (ii) administering at least one dose of a therapeutically effective amount of capecitabine to the subject about 12 to about 24 hours after administering the at least one dose of the effective amount of PCS6422;
- (iii) measuring metabolites comprising one or more of α-fluoro-β-alanine (FBAL), 5′-deoxy-5-fluorocytidine (5′-DFCR), doxifluridine (5′-DFUR), and 5-fluorouracil (5-FU) in a blood sample obtained from the subject;
- and
- (iv) determining whether the therapeutic regimen should be adjusted based on a therapeutic index comprising the metabolite measurements determined in step (iii).
2 more elements
Dependencies are inferred from the claim text.