Study of EC0489 for the Treatment of Refractory or Metastatic Tumors
This study has been completed.
Sponsor:
Endocyte
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT00852189
First received: February 25, 2009
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: EC0489, Injection Drug: EC20 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle |
Resource links provided by NLM:
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: | 65 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: EC0489, Injection
- Folic acid-technetium 99m conjugate
- Folatescan
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)
Other Name: Folic acid desacetylvinblastine hydrazide conjugate
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.
Other Names:
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).
Other Name: Folic acid desacetylvinblastine hydrazide conjugate
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.
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
- ≥ 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852189
Locations
| United States, Indiana | |
| Horizon Oncology Center | |
| Lafayette, Indiana, United States, 47905 | |
| United States, Maryland | |
| Greenebaum Cancer Center - University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute - Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| Great Lakes Cancer Institute - Michigan State University | |
| Lansing, Michigan, United States, 48910 | |
| Providence Cancer Institute | |
| Southfield, Michigan, United States, 48075 | |
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: | NCT00852189 History of Changes |
| Other Study ID Numbers: | EC-0489-01 |
| Study First Received: | February 25, 2009 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endocyte:
|
Cancer Phase 1 EC0489 EC20 |
Refractory Metastatic Experimental |
Additional relevant MeSH terms:
|
Folic Acid Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013