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

NCT03378297 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-10-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

Metformin

Metformin tablets 850 mg x 2 orally

DRUG

Acetylsalicylic acid

Acetylsalicylic acid tablets 160 mg x1 orally

DRUG

Olaparib

Olaparib capsules 300 mg x 2 orally

DRUG

Letrozole

Letrozol tablets 2.5 mg x 1 orally

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Line Bjørge, MD, PhD · Helse-Bergen HF

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378297 on ClinicalTrials.gov