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NCT00308269

Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)

NCT ID: NCT00308269

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-07-31

Brief Summary

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This is a Phase I clinical trial evaluating the safety and tolerability of escalating doses of vintafolide (EC145) in participants with relapsed or refractory advanced tumors. The primary objective of this study is to determine the safety and maximum tolerated dose of vintafolide given by intravenous bolus or infusion. The efficacy of the treatment will also be measured.

Detailed Description

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This is a dose escalation study of vintafolide administered by intravenous (IV) bolus or infusion during weeks 1 and 3 of a 4-week cycle to participants with solid tumors refractory to current therapies. Vintafolide 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 vintafolide treatment; however, lab research (research in test tubes and/or animals) using vintafolide has shown activity against tumors in animals. This activity in animal models suggests that vintafolide may be useful as chemotherapy against human cancers.

Conditions

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Cancer

Keywords

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Cancer Phase I EC145 Recurrent Refractory Solid Tumors Experimental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Vintafolide IV Bolus

Intervention Type DRUG

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

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

Group Type EXPERIMENTAL

Vintafolide IV Bolus

Intervention Type DRUG

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

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

Group Type EXPERIMENTAL

Vintafolide IV Bolus

Intervention Type DRUG

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

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

Group Type EXPERIMENTAL

Vintafolide IV Infusion

Intervention Type DRUG

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

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

Group Type EXPERIMENTAL

Vintafolide IV Infusion

Intervention Type DRUG

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

Interventions

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Vintafolide IV Bolus

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

Intervention Type DRUG

Vintafolide IV Infusion

Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endocyte

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Li J, Sausville EA, Klein PJ, Morgenstern D, Leamon CP, Messmann RA, LoRusso P. Clinical pharmacokinetics and exposure-toxicity relationship of a folate-Vinca alkaloid conjugate EC145 in cancer patients. J Clin Pharmacol. 2009 Dec;49(12):1467-76. doi: 10.1177/0091270009339740. Epub 2009 Oct 16.

Reference Type RESULT

PMID: 19837906 (View on PubMed)

Lorusso PM, Edelman MJ, Bever SL, Forman KM, Pilat M, Quinn MF, Li J, Heath EI, Malburg LM, Klein PJ, Leamon CP, Messmann RA, Sausville EA. Phase I study of folate conjugate EC145 (Vintafolide) in patients with refractory solid tumors. J Clin Oncol. 2012 Nov 10;30(32):4011-6. doi: 10.1200/JCO.2011.41.4946. Epub 2012 Oct 1.

Reference Type RESULT

PMID: 23032618 (View on PubMed)

Other Identifiers

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EC-FV-01

Identifier Type: OTHER

Identifier Source: secondary_id

8109-006

Identifier Type: -

Identifier Source: org_study_id