Clinical trial · Interventional
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company suspended development of product.
Summary
Brief summary (as posted)
This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant nematode anticoagulant protein c2 (rNAPc2) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety measured by major hemorrhage (NCI CTCAE v3.0 grade 3 or greater), during and up to 30 days after completion of study drug administration or, if treatment is ongoing, by 8 months after study enrollment (Stage I) or randomization (Stage II)
- timeFrame
- 30 days after study completion
Secondary outcomes (5)
- measure
- Safety measured by adverse events
- timeFrame
- 30 days after study completion
- measure
- Efficacy measured by new metastasis-free survival by 8 months
- timeFrame
- 8 months
- measure
- Survival by 8 months
- timeFrame
- 8 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
* Tissue diagnosis of adenocarcinoma of the colon or rectum * Documented metastatic disease with at least one measurable lesion by RECIST criteria * Previously treated with 5-FU-based chemotherapy in the form of FOLFIRI, FOLFOX, or XELOX plus bevacizumab as first-line chemotherapy and have recorded progressive disease during treatment or after discontinuation of treatment, when discontinuation of treatment occurred less than 6 months before enrollment (Stage I) or randomization (Stage II) * Estimated life expectancy of at least 6 months * Age 18 to 75 years * Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before enrollment * No other active malignancy for which the subject is currently receiving treatment (other than mCRC) * No ongoing therapy with or need for parenteral and oral antithrombotics including anticoagulants and anti-platelet agents (including aspirin) and thrombolytics * No contraindication to systemic anticoagulation * No contraindication to modified FOLFOX6 or FOLFIRI combination chemotherapy * No receipt of any investigational compound within 28 days of enrollment
References
Publications (0)
Data not yet available