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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00839631

Enrollment

Registered

2009-02-09

Start date

2009-03-31

Completion date

2012-04-30

Last updated

2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.

Brief summary

This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors

Interventions

DRUGEC D-3263 HCl

EC D-3263 HCl, capsules, 50 mg. Oral administration. Dose escalation cohorts (cycle one: single dose on Day 1, daily doses on day 8-28; subsequent cycles: 1 week drug holiday followed by 3 weeks of daily dosing). Expansion Cohort: daily dosing for 28 days followed by a single 7 day drug holiday (Cycle 1), continuing thereafter with daily dosing.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assess the safety of EC D-3263 HCl	weekly
Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily	weekly

Secondary

Measure	Time frame
Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing	periodically within the first month, weekly thereafter
preliminary assessment of antitumor activity	1 month, periodically thereafter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026