Study of EC145 for the Treatment of Recurrent or Refractory Solid Tumors
This study has been completed.
Sponsor:
Endocyte
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT00308269
First received: March 27, 2006
Last updated: March 7, 2012
Last verified: March 2012
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Purpose
This is a Phase I clinical trial evaluating the safety and tolerability of escalating doses of EC145 in patients with relapsed or refractory advanced tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: EC145, Injection |
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-FV-01: A Phase 1 Study of EC145 Administered in 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 hightest 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: No ]
Secondary Outcome Measures:
- Pharmacokinetic and pharmacodynamic parameters; Anti-tumor activity; Feasibility of regimen [ Time Frame: Obtained during the first cycle of therapy on Days 1 and 3 ] [ 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 ]
- anti-tumor activity [ Time Frame: Initial dose of study therapy to disease progression ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IV Bolus Dose |
Drug: EC145, Injection
Dose escalation from a starting dose of 1.2mg IV Bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4-Week Cycle to the Maximum Tolerated Dose (MTD) or Dose escalation from a starting dose of 2.5mg diluted in 100cc sterile Normal Saline (1 Hour Infusion)to the Maximum Tolerated Dose (MTD.
Other Name: Folic acid desacetylvinblastine conjugate
|
| Experimental: 1 Hour Infusion |
Drug: EC145, Injection
Dose escalation from a starting dose of 1.2mg IV Bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4-Week Cycle to the Maximum Tolerated Dose (MTD) or Dose escalation from a starting dose of 2.5mg diluted in 100cc sterile Normal Saline (1 Hour Infusion)to the Maximum Tolerated Dose (MTD.
Other Name: Folic acid desacetylvinblastine conjugate
|
Detailed Description:
This is a Phase I, dose escalation study of EC145 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with solid tumors refractory to current therapies. EC145 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 EC145 treatment; however, lab research (research in test tubes and/or animals) using EC145 has shown activity against tumors in animals. This activity in animal models suggests that EC145 may be useful as chemotherapy against human cancers.
The primary objective of this study is to determine the safety and maximum tolerated dose of EC145 given by intravenous bolus. The efficacy of the 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
- > or = to 4 weeks post therapeutic radiation of chemotherapy (> or = to 6 weeks for nitrosoureas and mitomycin C) and recovery from associated toxicities
- Negative serum pregnancy test for women of child-bearing potential and willingness to practice contraceptive methods
- Adequate bone marrow reserve, renal, and hepatic function
Exclusion Criteria:
- Concurrent hematological 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308269
Locations
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
Sponsors and Collaborators
Endocyte
Investigators
| Study Director: | Richard A Messmann, MD, MHS, BSc | Endocyte |
More Information
No publications provided
| Responsible Party: | Endocyte |
| ClinicalTrials.gov Identifier: | NCT00308269 History of Changes |
| Other Study ID Numbers: | EC-FV-01 |
| Study First Received: | March 27, 2006 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endocyte:
|
Cancer Phase I EC145 Recurrent |
Refractory Solid Tumors Experimental |
ClinicalTrials.gov processed this record on May 23, 2013