NCT03458221: STAPOVER

Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

Recruiting now Phase 2, PHASE3 Last updated 18 April 2023

What this trial tests

Phase 2, PHASE3 trial testing Letrozole Oral Product in Recurrent Ovarian Cancer in 148 participants. Currently enrolling.

Timeline

31 January 2023

Primary endpoint
1 October 2026

1 October 2026

Quick facts

Lead sponsor	Gynaecologisch Oncologisch Centrum Zuid
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	148
Start date	31 January 2023
Primary completion	1 October 2026
Estimated completion	1 October 2026
Sites	6 locations across Netherlands

Drugs / interventions tested

• Letrozole Oral Product — full drug profile →
• Bicalutamide Oral Product — full drug profile →
• Everolimus Oral Product — full drug profile →
• Itraconazole Oral Product — full drug profile →

Conditions studied

• Recurrent Ovarian Cancer — all drugs for Recurrent Ovarian Cancer →
• Signal Transduction Pathway Deregulation — all drugs for Signal Transduction Pathway Deregulation →
• Therapy-Associated Cancer — all drugs for Therapy-Associated Cancer →

Sponsor

Gynaecologisch Oncologisch Centrum Zuid — full company profile →

Who can join

18 and older, female only, with Recurrent Ovarian Cancer or Signal Transduction Pathway Deregulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dysregulated Signalling Pathways Driving Anticancer Drug Resistance.
   Bou Antoun N, Chioni AM. · · 2023 · cited 74× · PMID 37569598 · DOI 10.3390/ijms241512222
2. Functionalized Nanoparticles Targeting Tumor-Associated Macrophages as Cancer Therapy.
   He Y, de Araújo Júnior RF, Cruz LJ, Eich C. · · 2021 · cited 48× · PMID 34683963 · DOI 10.3390/pharmaceutics13101670
3. Current Treatments and New Possible Complementary Therapies for Epithelial Ovarian Cancer.
   Garrido MP, Fredes AN, Lobos-González L, Valenzuela-Valderrama M, et al · · 2021 · cited 25× · PMID 35052757 · DOI 10.3390/biomedicines10010077
4. Signal Transduction Pathway Activity in High-Grade, Serous Ovarian Carcinoma Reveals a More Favorable Prognosis in Tumors with Low PI3K and High NF-κB Pathway Activity: A Novel Approach to a Long-Standing Enigma.
   van Lieshout L, van de Stolpe A, van der Ploeg P, Bowtell D, et al · · 2020 · cited 14× · PMID 32961868 · DOI 10.3390/cancers12092660
5. The Role of Hedgehog Pathway in Female Cancers.
   Garcia N, Ulin M, Al-Hendy A, Yang Q. · · 2020 · cited 13× · PMID 33179013 · DOI 10.26502/jcsct.5079089
6. The "Road" to Malignant Transformation from Endometriosis to Endometriosis-Associated Ovarian Cancers (EAOCs): An mTOR-Centred Review.
   Hablase R, Kyrou I, Randeva H, Karteris E, et al · · 2024 · cited 12× · PMID 38893278 · DOI 10.3390/cancers16112160
7. Multiple Myeloma Relapse Is Associated with Increased NFκB Pathway Activity and Upregulation of the Pro-Survival BCL-2 Protein BFL-1.
   Spaan I, van de Stolpe A, Raymakers RA, Peperzak V. · · 2021 · cited 7× · PMID 34572895 · DOI 10.3390/cancers13184668
8. Old drugs, new challenges: reassigning drugs for cancer therapies.
   Czechowicz P, Więch-Walów A, Sławski J, Collawn JF, et al · · 2025 · cited 5× · PMID 40038587 · DOI 10.1186/s11658-025-00710-0