Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

Sponsor

Endocyte (Industry)

Overall Status

Completed

CT.gov ID

NCT00441870

Collaborator

(none)

Enrollment

Locations

Duration (Months)

25.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) [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]

Secondary Outcome Measures

Pharmacokinetic and pharmacodynamic parameters [Obtained during the first cycle of therapy on Days 1 and 3]
Anti-tumor activity [Initial dose of study therapy to disease progression]
Uptake of 99mTc-Ec20 in tumors and normal tissues [1-2 hours post-administration of 99mTc-EC20]
Safety and tolerability [Initiation of study therapy through 30 day post last dose of study therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Greenebaum Cancer Center - University of Maryland Medicine	Baltimore	Maryland	United States	21201
2	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
3	Nevada Cancer Institute	Las Vegas	Nevada	United States	89135