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A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 PEG-SN38) Administered Weekly for 3 Weeks in 4-Week Cycles in Patients With Advanced Solid Tumors or Ymphoma (EZN-2208-02)


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

Thank you

Trial Information

A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 PEG-SN38) Administered Weekly for 3 Weeks in 4-Week Cycles in Patients With Advanced Solid Tumors or Ymphoma (EZN-2208-02)


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic
solid tumor or lymphoma that is refractory to standard therapy

- Measurable or evaluable disease

- Score of 0 to 2 on the ECOG performance scale

Exclusion Criteria:

- Concurrent serious medical illness

- Known, clinically suspected, or history of central nervous system (CNS) tumor
involvement

- Active diarrhea

- Known history of coagulation disorder

- Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications

- Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes

- Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to
treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or
nitrosoureas) prior to the scheduled administration of EZN-2208.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD of i.v. EZN-2208 administered weekly for 3 weeks in a 4-week cycle and recommended Phase 2 dose of i.v. EZN-2208

Principal Investigator

Amita Patnaik, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

South Texas Accelerated Research Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

EZN-2208-02

NCT ID:

NCT00520390

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • Advanced Solid Tumors
  • Lymphoma
  • Neoplasms

Name

Location

South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229