A pilot study of the safety and tolerability of oral administration of PD L 506 and the subsequent diagnostic value of porphyrin concentration (coproporphyrin I / III, CP I / III) in urine in patients with the first occurrence of colorectal cancer and in healthy subjects.

Conditions

Colorectal Carcinoma

Brief summary

Number of Adverse Drug Reactions (ADRs) graded according to CTCAE v5.0., Number of discontinuations due to ADRs.

Detailed description

Change of CP I / III levels in CRC patient urine samples taken before PD L 506 administration to CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day, at Visit 1 (before NAT, for NAT patients only) and Visit 2 (before tumour resection) and Visits 3, 4 and 6 (after NAT / tumour removal)., Change of CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration before NAT / tumour removal (Visit 1 for NAT patients and Visit 2 for other patients) to after NAT / tumour removal (Visits 3, 4 and 6)., Change of CP I / III levels in healthy subject urine samples taken before PD L 506 administration to CP I / III levels in healthy subject urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day (Visit 2).

Related papers

No related papers found yet.

Interventions

DRUGGliolan 30 mg/ml powder for oral solution.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Adverse Drug Reactions (ADRs) graded according to CTCAE v5.0., Number of discontinuations due to ADRs.	—

Secondary

Measure	Time frame
Change of CP I / III levels in CRC patient urine samples taken before PD L 506 administration to CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day, at Visit 1 (before NAT, for NAT patients only) and Visit 2 (before tumour resection) and Visits 3, 4 and 6 (after NAT / tumour removal)., Change of CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration before NAT / tumour removal (Visit 1 for NAT patients and Visit 2 for other patients) to after NAT / tumour removal (Visits 3, 4 and 6)., Change of CP I / III levels in healthy subject urine samples taken before PD L 506 administration to CP I / III levels in healthy subject urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day (Visit 2).	—

Measure

Time frame

Change of CP I / III levels in CRC patient urine samples taken before PD L 506 administration to CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day, at Visit 1 (before NAT, for NAT patients only) and Visit 2 (before tumour resection) and Visits 3, 4 and 6 (after NAT / tumour removal)., Change of CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration before NAT / tumour removal (Visit 1 for NAT patients and Visit 2 for other patients) to after NAT / tumour removal (Visits 3, 4 and 6)., Change of CP I / III levels in healthy subject urine samples taken before PD L 506 administration to CP I / III levels in healthy subject urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day (Visit 2).

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Countries

Germany

Outcome results

None listed