IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC (IMPACT)
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|ClinicalTrials.gov Identifier: NCT03378297|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : August 28, 2019
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:
- Metformin tablets, 850 mg x 2 orally.
- Acetylsalicylic acid tablets, 160 mg x1 orally
- Olaparib capsules, 300 mg x 2 orally
- Letrozol tablets, 2.5 mg x 1 orally
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Metformin Drug: Acetylsalicylic acid Drug: Olaparib Drug: Letrozole||Early Phase 1|
The women who agree to participate in the study prior to the laparoscopic evaluation, will be allocated to different study groups according to the diagnostic evaluation performed as standard of care at the department. During inclusion in the first study cohort, the olaparib cohort (n=32), an additional 16 women are randomized as controls and will not receive neither any study drug nor placebo. The study is unblinded. There will not be randomized controls into the other study cohorts, as the control group collected will be utilized as controls for all study agents.
The women in Arm I will be included in the WOO trial, and will be treated with the study agent for 10-14 days prior to tumor reductive surgery, starting the day of laparoscopic surgery (+1 day). The treatment will be discontinued at the time of tumor reductive surgery.
Currently fourmore agents are evaluated as of particular interest, as well as feasible to introduce, in the WOO study set up: metformin, acetylsalicylic acid, olaparib, and letrozol. The first agent listed in the protocol, metformin, will be given to 32 consequtive women, and drug related analyses will thereafter be performed. The next 32 women included in the study will receive the next agent on the list, acetylsalicylic acid, while analyses for the metformin group is ongoing, and after the acetylsalicylic acid study group has been included the next agent on the list is introduced. Should any of the included women be non-eligable to receive one study drug, they will either receive the next agent on the list of the four study drugs, if eligable, or be included as control.
The women in Arm II who agree to participate in the study will not receive the study medication, but standard neoadjuvant chemotherapy until having decreased tumor load radiologically estimated and scheduled for optimal debulking procedure according to standard treatment of this group of patients. Samples from these women will be used as control in the translational part of the where we aim to identify potential molecular pathway(s) and cell type(s) that may be responsible for suboptimal debulking.
During the cancer-directed surgical procedure in participants in both Arms additional tissue samples from matching sites, preferably from tissues removed as part of the operation, as well as blood and urine samples, are obtained for comparative analysis. By use of the collected samples we can evaluate the clinical and molecular impact of the study agents among those triaged to primary cytoreductive surgery. Promising therapeutic targets identified might later be explored separately in one of the consequtive treatment study groups.
After the debulking surgery all women will follow the recommended standard of care, including chemotherapy and consolidating bevacisumab where indicated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The first treatment cohort has a randomized design 2:1 (olaparib 32:control 16). The study is unblinded. In the following treatment arms are initiated each will included patients (n=32) will be offered the study-prespecified treatment drug.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||IMPACT: A Phase 0 Randomized Window-of-Opportunity Study of Novel and Repurposed Therapeutic Agents in Women Triaged to Primary Surgery for Advanced Epithelial Ovarian Cancer in Stages IIIa - IV.|
|Actual Study Start Date :||May 4, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
|No Intervention: Feasibility study cohort|
Metformin tablets 850 mg x 2 orally
Experimental: Acetylsalicylic acid
Drug: Acetylsalicylic acid
Acetylsalicylic acid tablets 160 mg x1 orally
300 mg x 2
Olaparib capsules 300 mg x 2 orally
Letrozol tablets 2.5 mg x 1 orally
- Changes in the expression of biomarkers [ Time Frame: 3 months ]A characterization of the tumor tissues from each patient will be performed (in pair). For each drug a specific biomarker is selected. The changes in expression of the defined biomarkers represent the primary outcome parameters. biomarkers related to the study agents and operability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378297
|Contact: Line Bjørge, MD, PhD||+47 email@example.com|
|Contact: Liv Cecilie V Thomsen, MD, PhD||+47 firstname.lastname@example.org|
|Helse Bergen HF, Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5021|
|Contact: Liv Cecilie V Thomsen, MD, PhD +47 55975000 Liv.Vestrheim@uib.no|
|Contact: Line Bjørge, MD, PhD +47 55975000 email@example.com|
|Principal Investigator: Line Bjørge, MD, PhD|
|Sub-Investigator: Liv Cecilie V Thomsen, MD, PhD|
|Sub-Investigator: Kathrine Woie, MD, PhD|
|Sub-Investigator: Bjørn Tore Gjertsen, MD, PhD|
|Helse Stavanger HF, Stavanger University Hospital||Recruiting|
|Stavanger, Norway, 4068|
|Contact: Bent Fiane, MD +47 51518000 firstname.lastname@example.org|
|Contact: Cecilie F Torkildsen, MD +47 51518000 email@example.com|
|Principal Investigator: Bent Fiane, MD|
|Sub-Investigator: Cecilie F Torkildsen, MD|
|Sub-Investigator: Ragnar K Sande, MD, PhD|
|Principal Investigator:||Line Bjørge, MD, PhD||Helse-Bergen HF|