drugset / Trial / NCT03378297

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

NCT03378297

Phase 0 Completed 26 enrolled Haukeland University Hospital
RandomizedSingle-groupOpen-labelBasic science

Summary

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

Timeline

Start
2018-05-04
Primary completion
2023-01-05
Completion
2023-01-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 160 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Metformin Small molecule 850 mg Oral
Subject Olaparib Small molecule 300 mg Oral

Indications