Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT00441870
First received: February 27, 2007
Last updated: March 8, 2012
Last verified: March 2012

February 27, 2007
March 8, 2012
February 2007
November 2010   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD) [ Time Frame: Dose escalation to the highest 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: Yes ]
  • Maximum tolerated dose (MTD)
  • Safety
  • Tolerability
Complete list of historical versions of study NCT00441870 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic and pharmacodynamic parameters [ Time Frame: Obtained during the first cycle of therapy on Days 1 and 3 ] [ Designated as safety issue: No ]
  • Anti-tumor activity [ Time Frame: Initial dose of study therapy to disease progression ] [ Designated as safety issue: No ]
  • Uptake of 99mTc-Ec20 in tumors and normal tissues [ Time Frame: 1-2 hours post-administration of 99mTc-EC20 ] [ 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 ]
  • Pharmacokinetic and pharmacodynamic parameters
  • Anti-tumor activity
  • Uptake of 99mTc-Ec20 in tumors and normal tissues
Not Provided
Not Provided
 
Study of EC0225 for the Treatment of Refractory or Metastatic Tumors
Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 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 EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of 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: EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)
    Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
    Other Name: Folic acid desacetylvinblastine hydrazide conjugate
  • Drug: 99mTC-EC20 (Folic acid-technetium 99m conjugate)
    20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging
    Other Names:
    • Folic acid-technetium 99m conjugate
    • FolateScan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
November 2010
November 2010   (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
  • ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
  • Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
  • Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria:

  • Concurrent 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
  • Unable to tolerate conditions for radionuclide imaging
  • Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00441870
EC-0225-01
No
Endocyte
Endocyte
Not Provided
Study Director: Richard A. Messmann, MD, MHS, MSc Endocyte
Endocyte
March 2012

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