Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)
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ClinicalTrials.gov Identifier: NCT00308269 |
Recruitment Status :
Completed
First Posted : March 29, 2006
Last Update Posted : December 19, 2014
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Condition or disease | Intervention/treatment | Phase |
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Cancer | Drug: Vintafolide IV Bolus Drug: Vintafolide IV Infusion | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | July 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: Vintafolide 1.2 mg IV Bolus
Vintafolide 1.2 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
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Drug: Vintafolide IV Bolus
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate |
Experimental: Vintafolide 2.5 mg IV Bolus
Vintafolide 2.5 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
|
Drug: Vintafolide IV Bolus
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate |
Experimental: Vintafolide 4.0 mg IV Bolus
Vintafolide 4.0 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
|
Drug: Vintafolide IV Bolus
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate |
Experimental: Vintafolide 2.5 mg IV Infusion
Vintafolide 2.5 mg administered by a 1-hour IV infusion on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
|
Drug: Vintafolide IV Infusion
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate |
Experimental: Vintafolide 3.0 mg IV Infusion
Vintafolide 3.0 mg administered by a 1-hour IV infusion on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
|
Drug: Vintafolide IV Infusion
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate |
- Maximum Tolerated Dose During Cycle 1 Treatment [ Time Frame: Up to Day 26 in Treatment Cycle 1 ]Maximum Tolerated Dose (MTD) was defined as the highest dose that can safely be administered to a patient to produce acceptable, manageable and reversible toxicity. This level was further defined as the dose level at which no more than 1 of 6 participants had dose-limiting toxicity (DLT) and the level below the dose at which ≥2 of 6 participants had DLT.
- Number of Participants with Best Overall Tumor Response: Participants with Folate Receptor Positive Tumors at Baseline [ Time Frame: Up to Week 24 ]Tumor status was assessed according to Response Evaluation Criteria in Solid Tumors. Tumor responses used as a reference the sum of the longest diameter (LD) of the target lesions using imaging studies. Partial Response was defined as ≥30% decrease in LD. Stable Disease was defined as neither sufficient shrinkage or increase in LD to qualify as either Partial Response or Progressive Disease. Progressive Disease was defined as ≥20% increase in LD.
- Number of Participants with a Dose-Limiting Toxiciity During Cycle 1 Treatment [ Time Frame: Up to Day 26 in Treatment Cycle 1 ]Dose limiting toxicity was defined as an adverse event that is likely related to the study medication, and fulfills any one of the following criteria: Grade 2 non-hematological toxicity that fails to recover to a Grade 1 level or Baseline at the time that the next treatment cycle is due (with the exception of alopecia); Grade 3 non-hematological toxicity (except for nausea/vomiting without maximal symptomatic / prophylactic treatment); Grade 4 hematological toxicity; Toxicity that, in the opinion of the investigator, would prevent use of the drug dose or regimen by the general oncology community.
- Number of Participants with an Adverse Event Leading to Study Discontinuation During Cycle 1 Treatment [ Time Frame: Up to Day 26 in Treatment Cycle 1 ]An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the Sponsor's product whether or not related to the use of the product
- Number of Participants with Best Overall Tumor Response: All Treated Participants [ Time Frame: Up to Week 24 ]Tumor status was assessed according to Response Evaluation Criteria in Solid Tumors. Tumor responses used as a reference the sum of the longest diameter (LD) of the target lesions using imaging studies. Complete Response was defined as disappearance of all target lesions. Partial Response was defined as ≥30% decrease in LD. Stable Disease was defined as neither sufficient shrinkage or increase in LD to qualify as either Partial Response or Progressive Disease. Progressive Disease was defined as ≥20% increase in LD.
- Maximum Plasma Concentration (Cmax) of Vintafolide on Day 1 of Treatment Cycle 1 [ Time Frame: Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 1 of treatment cycle 1 ]Blood was collected from participants for determination of plasma vintafolide. The lower limit of quantitation for vintafolide was 10 ng/mL.
- Maximum Plasma Concentration (Cmax) of Vintafolide on Day 3 of Treatment Cycle 1 [ Time Frame: Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 3 of treatment cycle 1 ]Blood was collected from participants for determination of plasma vintafolide. The lower limit of quantitation for vintafolide was 10 ng/mL.
- Area Under the Plasma Concentration-Time Curve (AUC) of Vintafolide on Day 1 of Treatment Cycle 1 [ Time Frame: Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 1 of treatment cycle 1 ]Blood was collected from participants for determination of plasma vintafolide. The lower limit of quantitation for vintafolide was 10 ng/mL.
- Area Under the Plasma Concentration-Time Curve (AUC) of Vintafolide on Day 3 of Treatment Cycle 1 [ Time Frame: Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 3 of treatment cycle 1 ]Blood was collected from participants for determination of plasma vintafolide. The lower limit of quantitation for vintafolide was 10 ng/mL.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological diagnosis of neoplasm
- No effective standard therapeutic options
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- >=4 weeks post therapeutic radiation of chemotherapy >=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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308269
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 |
Responsible Party: | Endocyte |
ClinicalTrials.gov Identifier: | NCT00308269 |
Other Study ID Numbers: |
8109-006 EC-FV-01 ( Other Identifier: Endocyte ) |
First Posted: | March 29, 2006 Key Record Dates |
Last Update Posted: | December 19, 2014 |
Last Verified: | December 2014 |
Cancer Phase I EC145 Recurrent |
Refractory Solid Tumors Experimental |
Folic Acid Vinca Alkaloids Hematinics Vitamin B Complex Vitamins Micronutrients Nutrients |
Growth Substances Physiological Effects of Drugs Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |