Ignite Creation Date:
2024-05-06 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03057366
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2017-02-14
Brief Title:
A Study of 14 C-Pevonedistat in Participants With Advanced Solid Tumors
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Study to Assess Mass Balance Pharmacokinetics and Metabolism of 14C-Pevonedistat in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-11
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:
None
Brief Summary:
The purpose of this study is to assess the mass balance that is cumulative excretion of total radioactivity TRA in urine and feces and to characterize the pharmacokinetics PK of pevonedistat in whole blood plasma and urine and of TRA in plasma and whole blood following a single 1-hour infusion of 25 milligram per square meter mgm2 14C-pevonedistat intravenous IV solution containing approximately 60 to 85 microcurie mCi approximately 222-3145 megabecquerel MBq of TRA in participants with advanced solid tumors in Part A
Detailed Description:
The drug being tested in this study is called Pevonedistat Pevonedistat is being tested to treat people with advanced solid tumors
The study will enroll approximately 4 to 6 pharmacokinetics PK-evaluable participants in part A After completion of the mass balance and absorption distribution metabolism excretion ADME assessment in Part A of the study eligible participants will have the opportunity to continue into Part B at a secondary study site which would begin in approximately 2 weeks of completion of Part A
14C-Pevonedistat 25 mgm2
Part B optional Pevonedistat in combination with chemotherapy regimens Pevonedistat 25 mgm2 docetaxel 75 mgm2 or pevonedistat 20 mgm2 carboplatin 20 mgm2 paclitaxel 175 mgm2
All participants will receive study drug via intravenous route This multi-center trial will be conducted in Hungary Participants will remain confined to the study site for 9 to 14 days in Part A Participation in Part B is optional participants will be re-evaluated for inclusionexclusion criteria before administrating treatment Participants will undergo treatment in Part B for a maximum of 12 cycles 21 days cycle each and will include approximately 36 weeks for Part A and B combined Participants will attend an end of study visit 30 days after the last dose of study drug in both Part A and B
The study will enroll approximately 4 to 6 pharmacokinetics PK-evaluable participants in part A After completion of the mass balance and absorption distribution metabolism excretion ADME assessment in Part A of the study eligible participants will have the opportunity to continue into Part B at a secondary study site which would begin in approximately 2 weeks of completion of Part A
14C-Pevonedistat 25 mgm2
Part B optional Pevonedistat in combination with chemotherapy regimens Pevonedistat 25 mgm2 docetaxel 75 mgm2 or pevonedistat 20 mgm2 carboplatin 20 mgm2 paclitaxel 175 mgm2
All participants will receive study drug via intravenous route This multi-center trial will be conducted in Hungary Participants will remain confined to the study site for 9 to 14 days in Part A Participation in Part B is optional participants will be re-evaluated for inclusionexclusion criteria before administrating treatment Participants will undergo treatment in Part B for a maximum of 12 cycles 21 days cycle each and will include approximately 36 weeks for Part A and B combined Participants will attend an end of study visit 30 days after the last dose of study drug in both Part A and B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1169-6648 | REGISTRY | None | None |
| 2016-004132-37 | EUDRACT_NUMBER | WHO | None |