Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety of EC D-3263 HCl

Outcome Time Frame:

weekly

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

T08-1

NCT ID:

NCT00839631

Start Date:

March 2009

Completion Date:

April 2012

Related Keywords:

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

Name

Location

South Texas Accelerated Research Therapeutics (START)San Antonio, Texas  78229