Clinical trial · Interventional
Dose Escalation Study of EC D-3263 HCl in Advanced Solid Tumors
A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects With Advanced Solid Tumors
NCT00839631CI-TRIAL-00006831completedPhase 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)
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EC D-3263 HCl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Assess the safety of EC D-3263 HCl
- timeFrame
- weekly
- measure
- Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily
- timeFrame
- weekly
Secondary outcomes (2)
- measure
- Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing
- timeFrame
- periodically within the first month, weekly thereafter
- measure
- preliminary assessment of antitumor activity
- timeFrame
- 1 month, periodically thereafter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists * measurable or evaluable disease * \>= 18 years of age * ECOG of 0, 1 or 2 * no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl Exclusion Criteria: * Clinically significant coronary artery disease or conduction system abnormality * Coagulation disorder * Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl * Any major surgery within 28 days prior to receipt of EC D-3263 HCl
References
Publications (0)
Data not yet available
No reference posted for this study.