Study of EC0489 for the Treatment of Refractory or Metastatic Tumors

NCT ID: NCT00852189

Last Updated: 2012-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-04-30

Brief Summary

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Detailed Description

This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.

Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 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 EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.

Conditions

Cancer

Keywords

Cancer; Phase 1; EC0489; EC20; Refractory; Metastatic; Experimental

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

EC0489, Injection

PART A: Dose escalation from a starting dose of 1.0 mg/m2 IV bolus on Monday, Wednesday, and Friday Weeks 1 and 3 of a 4-week cycle to the Maximum Tolerated Dose (MTD)

Intervention Type: DRUG

EC20

20-25 mCi 99mTc-EC20 administered IV bolus 1-2 hours prior to imaging and at end of study for subjects who received 1 cycle or more of EC0489.

Intervention Type: DRUG

EC0489, Injection

PART B: Once PART A MTD is determined, PART B will begin. Dose escalation from a starting dose of 4.2 mg/m2 IV bolus once weekly in a 4-week cycle to the Maximum Tolerated Dose (MTD).

Intervention Type: DRUG

Other Intervention Names

Folic acid desacetylvinblastine hydrazide conjugate; Folic acid-technetium 99m conjugate; Folatescan; Folic acid desacetylvinblastine hydrazide conjugate

Eligibility 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
• ≥ 4 weeks post therapeutic radiation or recovered (or returned to baseline) from any acute toxicity associated with prior cytotoxic therapy. Patients previously treated with non-cytotoxic therapy (e.g., EGFR, VGEF, etc.) 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 EC0489)and willingness to practice contraceptive methods
• Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria

• Concurrent malignancies
• Women who are pregnant or breast-feeding
• Evidence of symptomatic brain metastases
• Receiving concomitant anticancer therapy (excluding supportive care)
• Requires palliative radiotherapy at time of study entry
• Requires antifolate therapy for comorbid conditions
• Heart failure characterized as greater than NYHA Class I
• History of myocardial infarct
• Any of the following baseline echocardiogram findings: valvular lesions (stenosis or insufficiency) characterized as greater than moderate, systolic ventricular impairment characterized as greater than mild, left ventricular ejection fraction < 55%, any feature of the echocardiogram that would confound interpretation of the serial echocardiograms required by the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endocyte

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A Messmann, MD, MHS, MSc

Role: STUDY_DIRECTOR

Endocyte

Locations

Horizon Oncology Center

Lafayette, Indiana, United States

Greenebaum Cancer Center - University of Maryland

Baltimore, Maryland, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Barbara Ann Karmanos Cancer Institute - Wayne State University

Detroit, Michigan, United States

Great Lakes Cancer Institute - Michigan State University

Lansing, Michigan, United States

Providence Cancer Institute

Southfield, Michigan, United States

Countries

United States

Other Identifiers

EC-0489-01

Identifier Type: -

Identifier Source: org_study_id