IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC

Sponsor
Haukeland University Hospital
Study ID
NCT03378297
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Metformin tablets 850 mg x 2 orally
  • Acetylsalicylic acid — DRUG
    Acetylsalicylic acid tablets 160 mg x1 orally
  • Olaparib — DRUG
    Olaparib capsules 300 mg x 2 orally
  • Letrozole — DRUG
    Letrozol tablets 2.5 mg x 1 orally

Study Details

The study will be conducted in women with advanced (stage IIIa-IV) ovarian cancer of the histologic subtype high grade serous carcinoma (HGSOC) who are going through a diagnostic laparoscopy. They will recieve treatment with a study agent for 10-14 days before surgery. They will be allocated to different study groups according to the diagnostic evaluation performed as standard of care at the department. The study is randomized and unblinded. The primary investigational agents are: 1. Metformin tablets, 850 mg x 2 orally. 2. Acetylsalicylic acid tablets, 160 mg x1 orally 3. Olaparib capsules, 300 mg x 2 orally 4. Letrozol tablets, 2.5 mg x 1 orally

Key Dates

Start date
May 4, 2018
Status verified
May 2024
Primary completion
Jan 5, 2023
Completion
Jan 5, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Feasibility study cohort
  • Experimental: Metformin
    850 mg
  • Experimental: Acetylsalicylic acid
    160 mg
  • Experimental: Olaparib
    300 mg x 2
  • Experimental: Letrozol
    2.5 mg

Primary Outcome Measure

Changes in the expression of biomarkers [ Time Frame: 3 months ]

Related Studies