drugset / Trial / NCT03378297
IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC
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
Publications
- Results Torkildsen CF, Austdal M, Iversen AC, Bathen TF, Giskeodegard GF, Nilsen EB, Iversen GA, Sande RK, Bjorge L, Thomsen LCV. Primary Treatment Effects for High-Grade Serous Ovarian Carcinoma Evaluated by Changes in Serum Metabolites and Lipoproteins. Metabolites. 2023 Mar 12;13(3):417. doi: 10.3390/metabo13030417.
- Torkildsen CF, Austdal M, Jarmund AH, Kleinmanns K, Lamark EK, Nilsen EB, Stefansson I, Sande RK, Iversen AC, Thomsen LCV, Bjorge L. New immune phenotypes for treatment response in high-grade serous ovarian carcinoma patients. Front Immunol. 2024 Jun 14;15:1394497. doi: 10.3389/fimmu.2024.1394497. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |