NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: NUC-1031 500 mg; NUC-1031 750mg
Intervention description: NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.; NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Platinum-resistant; ovarian neoplasm; antineoplastic agents; ovarian diseases; cancer of the ovary

Summary:

      This study was designed to evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and
      750mg/m2) in patients with ovarian cancer. The primary objective was to determine the
      anti-tumor activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed written informed consent.

          2. Original diagnosis and/or histological confirmation of high-grade serous, high-grade
             endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or
             primary peritoneal cancer.

          3. Time from the last line of platinum-based chemotherapy of less than 6 months.

          4. Received at least 3 prior chemotherapy-containing regimens.

          5. Age ≥18 years.

          6. Ability to comply with protocol requirements.

          7. Patients are not of childbearing potential or they must agree to use a physical method
             of contraception.

        Exclusion Criteria:

          1. Disease that progressed while receiving initial line of platinum-based chemotherapy.

          2. Received fewer than 3 prior chemotherapy-containing regimens.

          3. Prior therapy with single-agent gemcitabine.

          4. Prior history of hypersensitivity to gemcitabine.

          5. Prior chemotherapy, radiation (other than short cycle of radiation to reduce bone
             pain), treatment with a VEGF inhibitor, PARP inhibitor or immunotherapy within 21 days
             of first receipt of study drug. Hormone therapy within 14 days of first receipt of
             study drug.

          6. Residual side effects from chemotherapy or radiation, which have not gotten better
             except for nerve pain or tingling or hair loss.

          7. Patients who have a history of another type of cancer diagnosed within the past 5
             years, with the exception of adequately treated non-melanoma skin cancer curatively
             treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast.

          8. Presence of an serious illness, uncontrolled illness, or active infection requiring IV
             antibiotics.

          9. Presence of any serious illnesses, serious medical conditions, serious medical
             history, active bacterial or viral infections including hepatitis B or C, or known to
             be HIV positive.

         10. Currently pregnant, lactating or breastfeeding.

         11. History of blocked intestines because of ovarian cancer, unless fully resolved.