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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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Carcinoma

Thank you

Trial Information

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

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:

1. the 3rd sample is above the institution's ULN, and

2. 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

- No clinically significantly abnormal clinical laboratory tests or concomitant

- Ability and willingness to self-administer subcutaneous injections

- Although pregnancy is extremely unlikely in this patient population because of the
disease and prior treatment, patients who have the potential to become pregnant must
have a negative pregnancy test and must agree to practice an effective method of
contraception throughout the trial.

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

- Ascites

- Recent history of active infection, gastrointestinal bleeding, thromboembolic
disorders, or anticoagulation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

December 2006

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Asymptomatic
  • subcutaneous
  • CA125 Progression
  • Angstrom
  • Ångstrom
  • ovarian cancer
  • Carcinoma
  • Ovarian Neoplasms



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