Clinical trial · Interventional
Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients
Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
NCT03712371CI-TRIAL-00090805terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim study results were not favorable to continue with further enrollment.
Summary
Brief summary (as posted)
This study will examine the utility of chitosan for reduction of blood or tissue levels of AGEs in patients with prostate cancer who are clinically stable on androgen-deprivation therapy.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chitosan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chitosan Dose Escalation
- description
- The starting dose for Chitosan is 500mg twice daily, the second dose level is 1000mg twice daily, the third dose level is 1500mg twice daily and the fourth dose level is 2000mg twice daily. Safety evaluation is 28 days in length and total dose administration is 85 days in length.
- interventionNames
- Drug: Chitosan
Primary outcomes (1)
- measure
- Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity
- timeFrame
- 112 days
- description
- The maximum tolerated dose is defined as the dose that produces no more than 1 dose-limiting toxicity (DLT)in 6 subjects. Per protocol a DLT is defined as Grade 3 or higher hypophosphatemia and/ or Grade 3 or higher of any of the following toxicities, that the investigator deems related to chitosan, that do not improve or resolve within 7 days of onset: flatulence, increased stool bulkiness, bloating, nausea, heartburn
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: 1. Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer. 2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen or testosterone synthesis inhibitor. The current testosterone level must be documented to be \<50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain \<50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible. 3. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows: * Hematology parameters: ANC \>1000/mcL, platelets \> 100,000/mcL, Hgb \>8.0gm/dL * Renal Function: eGFR of ≥ 45mls/min using Cockgroft and Gault formula * Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5x ULN 4. Able to swallow and retain oral medication 5. ECOG performance status of 0 - 2 6. Ability to sign written informed consent 7. Testosterone level \<50ng/dL at time of enrollment. 8. Age 18 or older. 9. May have had prior radiation therapy, surgery, or cryoablation for primary prostate cancer 10. May have had prior cytotoxic chemotherapy for metastatic prostate cancer, prior treatment with genomically-targeted agents, or Provenge Exclusion: 1. Known allergy to chitosan or shellfish. 2. History of receiving more than 2 classes of ADT. 3. Chronic constipation (BM \< 3x weekly), history of malabsorption or history of daily laxative use. 4. Patients requiring medication administration with lunch or dinner or at a frequency of three or more times per day are not eligible. 5. Current use of chitosan, sevelamer, and/or glucosamine.
References
Publications (0)
Data not yet available
No reference posted for this study.