Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels

Ångstrom Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Carcinoma; Ovarian Cancer

Treatments: Drug: Å6 subcutaneous injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00083928

Å6-003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 illnesses

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind