Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-04-14 @ 2:04 PM
Study NCT ID:
NCT03161132
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2017-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin
Sponsor:
Grupo Español de Investigación en Cáncer de Ovario
Organization:
Study Overview
Official Title:
Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROLANDO
Brief Summary:
Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer.
Detailed Description:
The combination of Poly (ADP-ribose) polymerase (PARP) inhibitors with PLD may provide a synergistic effect in patients with advanced ovarian cancer, especially those with Homologous recombination deficiency (HRD), because of the decreased ability to repair chemotherapy-induced DNA damage. Preclinical studies with PARP inhibitors have shown potentiation of the cytotoxic effects of chemotherapeutic agents and a recent phase I study has shown the tolerability of the combination and efficacy in recurrent ovarian cancer. In this study, encouraging efficacy results were seen in ovarian cancer patients and were not limited by Germline BRCA1/2 (gBRCA) Mutations status or sensitivity to platinum therapy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-004850-14 | EUDRACT_NUMBER | None | View |