Extension Study of Bomedemstat (IMG-7289) in Patients With Myeloproliferative Neoplasms
Study Details
Study Description
Brief Summary
This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in patients with an MPN who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102 and IMG-7289-CTP-201 (referred to hereafter as 'feeder studies').
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bomedemstat All patients will be dosed with bomedemstat daily for 169 days with additional treatment continuing in patients deriving clinical benefit. |
Drug: Bomedemstat
Capsule (oral)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Patients with Treatment-Emergent Adverse Events and Serious Adverse Events [Up to ~14 days post last dose]
Incidence and severity of adverse events and serious adverse events will be measured using CTCAE criteria
- Number of Patients with Clinically Significant Change from Baseline in One or More Vital Signs [Baseline and up to Day 169 for each treatment period completed]
Vital signs will include resting heart rate, semi-supine systolic/diastolic blood pressure, respiratory rate and body temperature. Clinical significance will be determined by the investigator.
- Number of Patients with Clinically Significant Changes from Baseline in One or More Laboratory Parameters [Baseline and up to Day 169 for each treatment period completed]
Laboratory investigation will include hematology, coagulation, clinical chemistry and urinalysis. Clinical significance will be determined by the investigator.
- Myelofibrosis (MF) Patients Only: Change from Baseline in Spleen Volume [Baseline and approximately every 48 weeks throughout the study (up to 4 years)]
Spleen volume will be assessed by magnetic resonance imaging (MRI) (or computed tomography [CT] where applicable)
- Essential Thrombocythemia (ET) Patients Only: Change from Baseline in Platelet Counts Compared to Baseline [Baseline and up to Day 169 for each treatment period completed]
Other Outcome Measures
- Patient-reported Symptom Burden Response Rate [Baseline and up to Day 169 for each treatment period completed]
The patient-reported symptom burden response rate will be assessed using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Total Symptom Score (MPN10; derived from the MPN-SAF in patients with ET)
- Number of Patients who Achieve Complete Response (CR) or Partial Response (PR) [Approximately every 48 weeks throughout the study (up to 4 years)]
Response according to International Working Group for Myelofibrosis Research and Treatment and the European Leukemia Network response criteria
- Change from Baseline in Spleen Size [Baseline and approximately every 12 weeks throughout the study (up to 4 years)]
Spleen size is measured by palpation
- Changes in the Mutant (Variant) Allele Burden [Baseline and approximately every 48 weeks throughout the study (up to 4 years)]
Measured using genomic testing
- The Hematologic Effects of Bomedemstat on Complete Blood Count (CBC) [Baseline and approximately every 24 weeks throughout the study (up to 4 years)]
CBC will include red and white blood cell (RBC and WBC) and circulating blast cell counts
- ET Patients Only: Changes in Patient-reported Outcomes [Baseline and approximately every 24 weeks throughout the study (up to 4 years)]
Changes in patient-reported outcome are reported using the Patient Global Impression of Change questionnaire
- ET Patients Only: Assessment of the Number of Thrombotic or Hemorrhagic Events [Baseline and approximately every 24 weeks throughout the study (up to 4 years)]
Recorded on Adverse Event Case Report Form
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Completed at least one Treatment Period (TP) in a prior bomedemstat MPN protocol (such as, but not limited to, IMG-7289-CTP-102 or IMG-7289-CTP-201).
-
In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
Exclusion Criteria:
-
Ongoing participation in another investigational study (except observational studies).
-
A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
-
Current use of a prohibited medication (e.g., romiplostim).
-
Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
-
Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
-
Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami Leonard M. Miller | Miami | Florida | United States | 33136 |
| 2 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 3 | UMPC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 4 | Universittsklinikum Essen | Essen | Germany | 45147 | |
| 5 | Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 6 | Ospedale di Circolo-a Fondazione Macchi | Varese | VA | Italy | 2100 |
| 7 | Azienda Ospedaliera SS. Antonio | Alessandria | Italy | 15121 | |
| 8 | Azienda Ospedaliero Universitaria di Bologna | Pavia | Italy | 27100 | |
| 9 | Guy's and Saint Thomas' NHS Foundation Trus | London | United Kingdom | SE1 9RT |
Sponsors and Collaborators
- Imago BioSciences,Inc.
Investigators
- Study Director: Hugh Rienhoff, MD, Imago BioSciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMG-7289-CTP-202
- 2021-002452-37