Study of EC145 for the Treatment of Recurrent or Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Endocyte
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00308269
First received: March 27, 2006
Last updated: September 19, 2013
Last verified: September 2013
  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 Merck Sharp & Dohme Corp.:

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
Merck Sharp & Dohme Corp.
Endocyte
Investigators
Study Director: Richard A Messmann, MD, MHS, BSc Endocyte
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00308269     History of Changes
Other Study ID Numbers: 8109-006, EC-FV-01
Study First Received: March 27, 2006
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Cancer
Phase I
EC145
Recurrent
Refractory
Solid Tumors
Experimental

ClinicalTrials.gov processed this record on April 16, 2014