Study of EC0225 for the Treatment of Refractory or Metastatic Tumors - Full Text View

Purpose

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Condition	Intervention	Phase
Cancer	Drug: EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate) Drug: 99mTC-EC20 (Folic acid-technetium 99m conjugate)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Cancer

Drug Information available for: Folic acid Vitamin B Complex

U.S. FDA Resources

Further study details as provided by Endocyte:

Primary Outcome Measures:

Maximum tolerated dose (MTD) [ Time Frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic and pharmacodynamic parameters [ Time Frame: Obtained during the first cycle of therapy on Days 1 and 3 ] [ Designated as safety issue: No ]
Anti-tumor activity [ Time Frame: Initial dose of study therapy to disease progression ] [ Designated as safety issue: No ]
Uptake of 99mTc-Ec20 in tumors and normal tissues [ Time Frame: 1-2 hours post-administration of 99mTc-EC20 ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: Initiation of study therapy through 30 day post last dose of study therapy ] [ Designated as safety issue: Yes ]

Enrollment:	77
Study Start Date:	February 2007
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)

Other Name: Folic acid desacetylvinblastine hydrazide conjugate

20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging

Other Names:

Folic acid-technetium 99m conjugate
FolateScan

Detailed Description:

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Histological or cytological diagnosis of neoplasm
No effective standard therapeutic options
ECOG performance status of 0-2
≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria:

Concurrent malignancies
Women who are pregnant or lactating
Evidence of symptomatic brain metastases
Receiving concomitant anticancer therapy (excluding supportive care)
Requires palliative radiotherapy at time of study entry
Unable to tolerate conditions for radionuclide imaging
Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441870

Locations

United States, Maryland
Greenebaum Cancer Center - University of Maryland Medicine
Baltimore, Maryland, United States, 21201
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135

Sponsors and Collaborators

Endocyte

Investigators

Study Director:

Richard A. Messmann, MD, MHS, MSc

Endocyte

More Information

No publications provided

Responsible Party:	Endocyte
ClinicalTrials.gov Identifier:	NCT00441870 History of Changes
Other Study ID Numbers:	EC-0225-01
Study First Received:	February 27, 2007
Last Updated:	March 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endocyte:

Cancer
Phase 1
EC0225
EC20

Refractory
Metastatic
Experimental

Additional relevant MeSH terms:

Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013