Clinical trial · Interventional
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers
NCT00031616CI-TRIAL-00013076unknownPhase 1 / Phase 2ClinicalTrials.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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brivudine phosphoramidate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma that has progressed during or within 6 months of fluoropyrimidine-based therapy * Prior treatment with irinotecan with or without fluorouracil * Evaluable or measurable disease * Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal * No meningeal or CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL (regardless of liver metastases) * AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present) * PT and INR normal * PTT normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 50 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No known hypersensitivity to NB1011 or any excipient or vehicle in its formulation * No active or uncontrolled serious bacterial, viral, fungal, or parasitic infection * No prior or concurrent alcohol abuse or dependency * No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No concurrent medical or psychological condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * Recovered from prior anticancer chemotherapy * No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents Endocrine therapy: * Not specified Radiotherapy: * Recovered from prior anticancer radiotherapy * No concurrent radiotherapy except palliative radiotherapy (to control a fracture or pain) provided index lesions are not involved Surgery: * Recovered from prior anticancer surgery Other: * At least 30 days since prior investigational agents * No other concurrent anticancer therapy * No concurrent disulfiram
References
Publications (0)
Data not yet available
No reference posted for this study.