Clinical trial · Interventional
Nitric Oxide-Releasing Acetylsalicyclic Acid in Preventing Colorectal Cancer in Patients at High Risk of Colorectal Cancer
Phase I Multiple-Dose Safety, Pharmacokinetic and Pharmacodynamic Clinical Study of Nitric Oxide Releasing Aspirin (NCX 4016)
NCT00331786CI-TRIAL-00001995completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of nitric oxide-releasing acetylsalicyclic acid may prevent colorectal cancer. PURPOSE: This randomized phase I trial is studying the side effects and best dose of nitric oxide-releasing acetylsalicyclic acid in preventing colorectal cancer in patients at high risk of colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| nitric oxide-releasing acetylsalicylic acid derivative | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effects of nitric oxide-releasing acetylsalicyclic acid (NCX 4016) on aberrant cryptic foci (ACF) multiplicity after the second dose at 6 months
Secondary outcomes (5)
- measure
- Pharmacokinetic profile by blood, urine, and colon tissue sampling
- measure
- Incidence of ACF as measured by magnification chromoendoscopy
- measure
- Assessment of biomarkers expressed in colon tissue, including PGE2 (measured by immunoassay), COX-1, COX-2, NF-kB, and β-catenin (measured by immunohistochemistry) at baseline and at the final visit
- measure
- Data on C-Reactive protein as a marker for inflammation
- measure
- Safety and tolerability of long-term oral administration of NCX 4016 as measured by NCI CTCAE v3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * At risk for colorectal cancer * History of histologically proven sporadic colon adenomas or colon cancer * At least 5 aberrant cryptic foci on sigmoidoscopy * Less than 20 prior cumulative adenomas and no heredity nonpolyposis colorectal cancer * No significant asymptomatic lesions on sigmoidoscopy, including any of the following: * Inflammation * Strictures * Anorectal lesions * Fistulae * Vascular lesions * No adenomas or colon carcinomas on flexible sigmoidoscopy * No history of gastrointestinal (GI) cancer other than colorectal cancer * No inherited colorectal cancer syndromes PATIENT CHARACTERISTICS: * No other GI mucosal epithelial diseases (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption) * No active peptic ulcer disease * No history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) * No known or suspected alcohol ( \> 5 glasses of wine or beer per day), drug, or medication abuse * No quantitative or qualitative platelet or coagulation abnormalities * No personal or family history of a bleeding disorder * No uncontrolled diabetes * No uncontrolled hypertension, or chronic congestive heart failure (New York Heart Association class II-IV heart disease) * No myocardial infarction, transient ischemic attack, or stroke within the past 6 months * No equilibrium disorders affecting gait or ability to stand that would preclude study participation * No involuntary change in weight (up or down) of ≥ 15% of usual body weight within the past year * Creatinine ≤ 2.0 mg/dL * No chronic liver disease or pancreatitis * No allergies to aspirin * No prior severe adverse reactions to NSAIDs such as asthma, GI bleeding, or renal insufficiency * No institutionalized, mentally disabled patients * No prisoners * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test PRIOR CONCURRENT THERAPY: * No concurrent antibiotic prophylaxis * More than 7 days since prior nonsteroidal anti-inflammatory drug (NSAID) treatment, including aspirin * No concurrent frequent use (\> 7 days in previous month) of NSAIDs, cyclooxygenase (COX)-2 inhibitors, nitrovasodilators, or oral corticosteroids * No concurrent macronutrient consumption below the 1st or above the 99th percentile of U.S. consumption * No concurrent anticoagulants, ticlopidine, and clopidogrel * More than 3 months since prior general anesthesia * More than 3 months since prior investigational agents * No concurrent NSAIDs, including aspirin or COX-2 inhibitors * Acetaminophen allowed * No concurrent nitrovasodilating drugs * More than 3 months since prior participation in other investigational trials
References
Publications (0)
Data not yet available
No reference posted for this study.