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NCT03470805

Olaparib After Response to Trabectedin-pegylated Liposomal Doxorubicin in Recurrent Ovarian Carcinoma

Completed Phase 2 Last updated 23 September 2022
What this trial tests

Phase 2 trial testing Olaparib in Ovarian Cancer in 9 participants. Completed in 27 July 2022.

Timeline
21 June 2018
Primary endpoint
27 July 2022
27 July 2022

Quick facts

Lead sponsorGrupo Español de Investigación en Cáncer de Ovario
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date21 June 2018
Primary completion27 July 2022
Estimated completion27 July 2022
Sites16 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Grupo Español de Investigación en Cáncer de Ovario — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Epithelial ovarian cancer harbours 20% Breast Cancer gene (BRCA)1/2 mutations independently of family history. Poly ADP ribose polymerase (PARP) inhibitors (PARPi) have shown clinical activity among patients with homologous recombination deficiency (HRD) and specifically among BRCA1/2 mutation carriers. The European Medicines Agency (EMA) approved the use of olaparib as maintenance therapy "as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy". Trabectedin and Pegylated liposomal doxorubicin (PLD) have shown relevant activity in relapsed epithelial ovarian cancer. In the relapse with Treatment-free interval of last platinum (TFIp) between 6 and 12 months this efficacy translated into an increase in Overall survival (OS) and Progression free survival (PFS). There is an increase of hypersensitivity reactions (HSR) among platinum sensitive patients, that reaches 44% in third line and does not always allow for platinum use despite desensitization protocols. In relapse with TFIp between 6-12 months the use of Trabectedin+PLD is accepted in guidelines and consensus. Following clinical BRCAness criteria a group of patients that harbours up to 50% of BRCA1/2 mutations can be selected. Olaparib has been licensed according to EMA for maintenance in BRCA mutated patients after response to platinum following Study 19 phase II trial and further confirmed with phase III SOLO-2 data. However there is no evidence of the benefit of adding olaparib after Trabectedin+PLD response among BRCA1/2 carriers. The combination of Trabectedin+PLD, as well as both single drugs, have shown higher activity among BRCA1/2 carriers.

Publications & conference data

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

  1. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
    Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
  2. Current status and future prospects of PARP inhibitor clinical trials in ovarian cancer.
    Jiang X, Li W, Li X, Bai H, et al · · 2019 · cited 75× · PMID 31191001 · DOI 10.2147/cmar.s200524
  3. Macrophages as a Therapeutic Target in Metastatic Prostate Cancer: A Way to Overcome Immunotherapy Resistance?
    Martori C, Sanchez-Moral L, Paul T, Pardo JC, et al · · 2022 · cited 43× · PMID 35053602 · DOI 10.3390/cancers14020440
  4. Synthetic Lethality in Ovarian Cancer.
    Chandrasekaran A, Elias KM. · · 2021 · cited 34× · PMID 34518297 · DOI 10.1158/1535-7163.mct-21-0500
  5. INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum lin
    Colombo N, Gadducci A, Sehouli J, Rulli E, et al · · 2023 · cited 21× · PMID 36759720 · DOI 10.1038/s41416-022-02108-7
  6. DNA Damage Response Alterations in Ovarian Cancer: From Molecular Mechanisms to Therapeutic Opportunities.
    Ovejero-Sánchez M, González-Sarmiento R, Herrero AB. · · 2023 · cited 16× · PMID 36672401 · DOI 10.3390/cancers15020448

Verify or expand the search:

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