Phase I/II study of prevention of Colorectal Cancer CRC with Allopurinol in High-Risk Subjects - APAC

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001084-27-IT

Enrollment

Registered

2007-03-01

Start date

2006-06-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHEMOPREVENTION OF COLORECTAL CANCER MedDRA version: 9.1 Level: LLT Classification code 10048832 Term: Colon adenoma

Interventions

Trade Name: ZYLORIC*30CPR 300MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Allopurinol CAS Number: 315-30-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age 8805; 18 years, 75 years; 2.Provision of written informed consent; 3.Subjects with one ore more colorectal adenomatous polyps diam. 8805; 1 cm ; 4.Adequate renal and hepatic function; 5.Performance status 8804; 1; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Presence of iperplastic polyps and/or flat adenomas; Subjects with pre-existing CCR; Presence of carcinoma tissue in adenoma; Previous allopurinol assumption within 6 months ; Pregnancy or breast feeding women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment ; Known severe hypersensitivity to allopurinol or any of the excipients of this product; Geographic inaccessibility or proven difficulty to assure adequate compliance; Renal failure grade 1 creatinine 1.5 x ULN ; Acute Gout; Subjects in anticoagulant therapy with dicumarol.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of the study is to estimate the activity of allopurinol compared with placebo on the change in cell proliferation by assessment of Ki-67;Secondary Objective: Secondary objectives are to investigate the effects of allopurinol on potential biomarkers measured as a change from the baseline Bcl-2, COX-2, topoisomerase-II-a as a measure of apoptosis, IGF-I, IGFBP-3 and IGF-I/IGFBP-3 inflammation indexes u-PCR We will also evaluate the safety and tolerability of the two different scheduled doses of 100mg and 300mg /day of allopurinol.;Primary end point(s): The primary endpoint of the study is to estimate the activity of allopurinol compared with placebo on the change in cell proliferation by assessment of Ki-67, a biomarker of cell proliferation, in CRC tissue at baseline tumor or polyp biopsy and after 4 weeks of allopurinol treatment surgical resection specimen .	—

Measure

Time frame

Main Objective: The primary endpoint of the study is to estimate the activity of allopurinol compared with placebo on the change in cell proliferation by assessment of Ki-67;Secondary Objective: Secondary objectives are to investigate the effects of allopurinol on potential biomarkers measured as a change from the baseline Bcl-2, COX-2, topoisomerase-II-a as a measure of apoptosis, IGF-I, IGFBP-3 and IGF-I/IGFBP-3 inflammation indexes u-PCR We will also evaluate the safety and tolerability of the two different scheduled doses of 100mg and 300mg /day of allopurinol.;Primary end point(s): The primary endpoint of the study is to estimate the activity of allopurinol compared with placebo on the change in cell proliferation by assessment of Ki-67, a biomarker of cell proliferation, in CRC tissue at baseline tumor or polyp biopsy and after 4 weeks of allopurinol treatment surgical resection specimen .

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026