A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of Å6 in Patients With Asymptomatic CA125 Progression of Epithelial Ovarian Cancer After First-Line Chemotherapy

Ångstrom Pharmaceuticals24 sites in 1 country60 target enrollmentMay 2004

ConditionsOvarian Cancer Primary Peritoneal Carcinoma

DrugsÅ6 subcutaneous injection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: Ångstrom Pharmaceuticals
Enrollment: 60
Locations: 24
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

December 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ångstrom Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Females ≥18 years of age
•Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma
•Completion of first-line chemotherapy
•Clinical remission as a result of chemotherapy
•History of normal CA125 level after initial course of therapy
•CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually \>= 28 days apart, provided that:
•the 3rd sample is above the institution's ULN, and
•the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN
•No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)
•ECOG Performance Status of 0 or 1

Exclusion Criteria

•Persistent adverse events due to agents administered more than 4 weeks earlier
•More than 1 course of previous chemotherapy for the qualifying cancer
•Disease requiring chemotherapy or radiotherapy
•Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation