Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480086
Status:
TERMINATED
Last Update Posted:
2023-08-29
First Post:
2020-07-20
Brief Title:
Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1b Study of Mivebresib Alone or in Combination With Ruxolitinib or Navitoclax in Subjects With Myelofibrosis
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic considerations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Myelofibrosis MF is a bone marrow illness that affects blood-forming tissues in the body MF disturbs the bodys normal production of blood cells causing extensive scarring in the bone marrow This leads to severe anemia weakness fatigue and an enlarged spleen The purpose of this study is to see how safe and tolerable mivebresib is when given alone and in combination with navitoclax or ruxolitinib for adult participants with MF
Mivebresib is an investigational drug being developed for the treatment of MF The study has 4 segments - A B C and D In Segment A the safe dosing regimen of mivebresib is identified and then given alone as monotherapy In Segment B C and D combination therapies of mivebresib with either ruxolitinib or navitoclax are given Adult participants with a diagnosis of MF will be enrolled Around 130 participants will be enrolled in 60 sites worldwide
In Segment A participants will receive different doses and schedules of oral mivebresib tablet to identify a safe dosing regimen Additional participants will be enrolled at the identified monotherapy dosing regimen In Segment B participants will receive oral ruxolitinib and mivebresib will be given as add-on therapy In Segment C participants will receive mivebresib and oral navitoclax In Segment D participants will receive mivebresib and ruxolitinib Participants will receive treatment until disease progression or the participants are not able to tolerate the study drugs
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of treatment will be checked by medical assessments blood and bone marrow tests checking for side effects and completing questionnaires
Mivebresib is an investigational drug being developed for the treatment of MF The study has 4 segments - A B C and D In Segment A the safe dosing regimen of mivebresib is identified and then given alone as monotherapy In Segment B C and D combination therapies of mivebresib with either ruxolitinib or navitoclax are given Adult participants with a diagnosis of MF will be enrolled Around 130 participants will be enrolled in 60 sites worldwide
In Segment A participants will receive different doses and schedules of oral mivebresib tablet to identify a safe dosing regimen Additional participants will be enrolled at the identified monotherapy dosing regimen In Segment B participants will receive oral ruxolitinib and mivebresib will be given as add-on therapy In Segment C participants will receive mivebresib and oral navitoclax In Segment D participants will receive mivebresib and ruxolitinib Participants will receive treatment until disease progression or the participants are not able to tolerate the study drugs
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of treatment will be checked by medical assessments blood and bone marrow tests checking for side effects and completing questionnaires
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001226-65 | EUDRACT_NUMBER | None | None |