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

March 27, 2006
September 19, 2013
March 2006
August 2007   (final data collection date for primary outcome measure)
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 ]
  • Maximum tolerated dose (MTD)
  • Safety
  • Tolerability
Complete list of historical versions of study NCT00308269 on ClinicalTrials.gov Archive Site
  • 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 ]
Pharmacokinetic and pharmacodynamic parameters; Anti-tumor activity; Feasibility of regimen
Not Provided
Not Provided
 
Study of EC145 for the Treatment of Recurrent or Refractory Solid Tumors
Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
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: IV Bolus Dose
    Intervention: Drug: EC145, Injection
  • Experimental: 1 Hour Infusion
    Intervention: Drug: EC145, Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2008
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00308269
8109-006, EC-FV-01
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Endocyte
Study Director: Richard A Messmann, MD, MHS, BSc Endocyte
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP