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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.
EU CTIS ID: 2023-508668-31-00
What this study is testing
To investigate the safety and tolerability of repeated oral administration of 300 mg PD L 506 in subjects with the first occurrence of CRC (Cohort 1) and of single oral administration of 300 mg PD L 506 in subjects without CRC (Healthy Subjects, Cohort 2).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent after comprehensive information.
- Male or female ≥18 years of age.
- CRC patients (cohort 1 only) with newly diagnosed, non-metastatic, resectable colorectal cancer (< UICC IV) must meet the following criteria: Confirmed histopathological diagnosis and anti-cancer therapy for CRC not started.
- Healthy subject (cohort 2 only) meeting the following criteria: Has undergone colonoscopy that extended to the ileocecal valve and was negative for malignancy within 5 years before screening visit
- Willingness of women of childbearing/ reproductive potential and male subjects to use highly effective contraception (Pearl index <1) consistently and correctly for the duration of the clinical trial period through the last follow-up visit required by the protocol.
- Willingness of pre-menopausal female subjects who are of childbearing potential to obtain a negative serum pregnancy test max. 72 h prior to first application of PD L 506 and during the conduct of the clinical trial as appropriate.
You likely can't join if
- Subject is not willing to give or sign the informed consent and/or not able to comply with scheduled visits, treatment plan, laboratory tests, and other clinical trial procedures.
- Previous allogenic bone marrow transplantation or insufficient bone marrow function.
- Any psychological, cognitive, familial, sociological, or geographical condition that, in the investigator’s opinion, compromises the patient’s ability to understand the patient information, to give informed consent or to comply with the clinical trial protocol.
- Known hypersensitivity to porphyrins or the active substance 5-ALA HCl.
- Known diagnosis of acute or chronic types of porphyria.
- Clinically significant renal or hepatic impairment including severe chronic conditions/co-morbidities.
See the full eligibility criteria
Who can join
- Signed and dated informed consent after comprehensive information.
- Male or female ≥18 years of age.
- CRC patients (cohort 1 only) with newly diagnosed, non-metastatic, resectable colorectal cancer (< UICC IV) must meet the following criteria: Confirmed histopathological diagnosis and anti-cancer therapy for CRC not started.
- Healthy subject (cohort 2 only) meeting the following criteria: Has undergone colonoscopy that extended to the ileocecal valve and was negative for malignancy within 5 years before screening visit
- Willingness of women of childbearing/ reproductive potential and male subjects to use highly effective contraception (Pearl index <1) consistently and correctly for the duration of the clinical trial period through the last follow-up visit required by the protocol.
- Willingness of pre-menopausal female subjects who are of childbearing potential to obtain a negative serum pregnancy test max. 72 h prior to first application of PD L 506 and during the conduct of the clinical trial as appropriate.
What rules you out
- Subject is not willing to give or sign the informed consent and/or not able to comply with scheduled visits, treatment plan, laboratory tests, and other clinical trial procedures.
- Previous allogenic bone marrow transplantation or insufficient bone marrow function.
- Any psychological, cognitive, familial, sociological, or geographical condition that, in the investigator’s opinion, compromises the patient’s ability to understand the patient information, to give informed consent or to comply with the clinical trial protocol.
- Known hypersensitivity to porphyrins or the active substance 5-ALA HCl.
- Known diagnosis of acute or chronic types of porphyria.
- Clinically significant renal or hepatic impairment including severe chronic conditions/co-morbidities.
- Any current diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the clinical trial (at the discretion of the investigator).
- Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days directly preceding treatment or within 5 plasma half-life’s of the preceding trial drug, whatever is longer.
- Pregnancy or breastfeeding.
- Metastatic colorectal cancer (UICC IV).
- Current diagnosis of any other tumour (malignant or benign).
- Suffers from Ulcerative Colitis or Crohn’s Disease.
- Intercurrent severe infection.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.