Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607692
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Study in Children and Adolescents of 177Lu-DOTATATE Lutathera Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor SSTR LuPARPed
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-arm Open-label Phase II Study in Children and Adolescents of 177Lu-DOTATATE Lutathera Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor SSTR LuPARPed
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUPARPED
Brief Summary:
Study in children and adolescents of 177Lu DOTATATE Lutathera combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors SSTR LuPARPed
Detailed Description:
Relapsedrefractory RR solid tumours at the paediatric age have a dismal prognosis 5-year overall survival OS ampampamplt20 There is growing evidence about the somatostatin receptor SSTR expression in paediatric tumours which opens a new diagnostic and therapeutic tool Somatostatin receptor-targeted therapy with 177Lu-DOTA0-Tyr3-octreotate 177LuLu DOTA-TATE 177Lu-DOTATATE Lutathera has been approved by the EMA 2017 and the FDA 2018 for the treatment of adults with midgut neuroendocrine tumours after the excellent results achieved in the phase III NETTER-1 study
177Lu-DOTATATE is already being explored as monotherapy in children with RR high-risk neuroblastoma CNS tumours or meningiomas in 2 pilot studies and 4 clinical trials ISRCTN98918118 NCT04903899 NCT03966651 NCT05278208 There are two on going clinical trials exploring the recommended phase 2 dose RP2D of 177Lu-DOTATATE in children ampampampampamplt12 years old but results are still pending
The results show promising but insufficient results Because of its beta particle emission 177Lu-DOTATATE mainly produces DNA single-strand breaks SSBs that are easily repaired by the organism In order to enhance its effect the investigators propose its combination with PARP inhibitors iPARP so that the SSBs could not be repaired and would lead to the formation of DNA double strand breaks DSBs and subsequently to cell death This combination is already being explored in different clinical trials in adults with neuroendocrine tumours and prostate cancer An interesting study analysed the perfect scheme for the 177Lu-DOTATATE and olaparib combination and concluded that olaparib should be delayed 24 hours after 177Lu-DOTATATE administration in order to facilitate normal tissue repair without decreasing antitumoural activity It also concludes that there is no benefit in continuing olaparib after 4 weeks of continuous treatment Olaparib has also been administered in children and there is today a recommended phase 2 dose 1875 mgm2 BID
177Lu-DOTATATE is already being explored as monotherapy in children with RR high-risk neuroblastoma CNS tumours or meningiomas in 2 pilot studies and 4 clinical trials ISRCTN98918118 NCT04903899 NCT03966651 NCT05278208 There are two on going clinical trials exploring the recommended phase 2 dose RP2D of 177Lu-DOTATATE in children ampampampampamplt12 years old but results are still pending
The results show promising but insufficient results Because of its beta particle emission 177Lu-DOTATATE mainly produces DNA single-strand breaks SSBs that are easily repaired by the organism In order to enhance its effect the investigators propose its combination with PARP inhibitors iPARP so that the SSBs could not be repaired and would lead to the formation of DNA double strand breaks DSBs and subsequently to cell death This combination is already being explored in different clinical trials in adults with neuroendocrine tumours and prostate cancer An interesting study analysed the perfect scheme for the 177Lu-DOTATATE and olaparib combination and concluded that olaparib should be delayed 24 hours after 177Lu-DOTATATE administration in order to facilitate normal tissue repair without decreasing antitumoural activity It also concludes that there is no benefit in continuing olaparib after 4 weeks of continuous treatment Olaparib has also been administered in children and there is today a recommended phase 2 dose 1875 mgm2 BID
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None