A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
- Conditions
- Participants who are transfusion-dependent or present with symptomatic anemiafor MDS participants who are ineligible to receive or have not responded to available therapies for anemia and for MM after failure of available standard treatments.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-002771-35-FR
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Age 18 years or older at the time of signing the ICF.
3. ECOG performance status of the following:
a. 0 or 1 for the dose-escalation stages.
b. 0, 1, or 2 for the dose-expansion stage.
4. Life expectancy > 6 months.
5. Agreement to avoid pregnancy or fathering children based on the criteria below:
a. Men must agree to take appropriate precautions to avoid fathering children from screening through 90 days after the last dose of study drug
and must refrain from donating sperm during this period.
b. Women with childbearing potential must have a negative serum pregnancy test at
screening before the first dose must agree to take appropriate precautions to avoid pregnancy from screening through the safety follow-up visit, and must not donate oocytes during this period.
c. Women without childbearing potential are eligible.
6. Participants who are transfusion-dependent or present with symptomatic anemia, defined
as follows:
a. Anemia: an Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements
b. Transfusion-dependent: participant has received at least 4 units of RBC transfusions
during the 28 days immediately preceding C1D1 OR has received at least 4 units of RBC transfusions in the 8 weeks immediately preceding C1D1, for an Hgb level of
< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
7. Ineligible to receive or have not responded to available therapies for anemia such as
ESAs or lenalidomide.
8. Not requiring cytoreductive therapy other than hydroxyurea.
9. BM and peripheral blood myeloblast count < 10%.
10. Histologically confirmed diagnosis of the following (according to the 2016 WHO criteria:
a. MDS.
b. CMML.
c. Unclassifiable MDS/MPN overlap syndromes
11. Histologically confirmed diagnosis of MM
12. After failure of available standard treatments
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
2. Any major surgery within 28 days before the first dose of study drug.
3. Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,
biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating
agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter)
before the first dose of study drug.
a. Exceptions include glucocorticoids and hydroxyurea
4. Undergoing treatment with another investigational medication or having been treated
with an investigational medication within 28 days before the first dose of study drug.
5. Undergoing treatment with ESAs, granulocyte colony-stimulating factor or
granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any
time within 28 days before the first dose of study drug.
6. Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within
28 days or 5 half-lives (whichever is longer) before the first dose of study drug or
expected to receive such treatment during the study
7. Any prior radiation therapy within 28 days before the first dose of study drug.
8. Presence of any hematologic malignancy other than MDS or MM, as applicable.
9. Active invasive malignancy over the previous 5 years
10. Known active disease involving the CNS.
11. History of clinically significant or uncontrolled cardiac disease
12. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically
meaningful.
13. Presence of chronic or current active infectious disease requiring systemic antibiotic,
antifungal, or antiviral treatment.
14. Diagnosis of chronic liver disease
15. Known active hepatitis A, HBV, or HCV infection or known HIV infection.
16. Unwillingness to be undergo transfusion with blood components, including RBC packs
and platelet transfusions.
17. Any condition in the investigator's judgment that would interfere with full participation in
the study including administration of study drug and attending required study visits;
pose a significant risk to the participant; or interfere with interpretation of study data.
18. Active alcohol or drug addiction that would interfere with the participant's ability to
comply with the study requirements.
19. Gastroesophageal reflux disease not controlled by medication within 28 days before the first dose of study drug.
20. Presence of any unresolved toxicity = Grade 2 from previous therapy except for stable
chronic toxicities (= Grade 2) not expected to resolve, such as stable Grade 2 peripheral
neuropathy.
21. Known hypersensitivity, severe reaction, or any known contraindications to the use of
any of the active substances or excipients in INCB000928.
22. Women who are pregnant or breastfeeding.
23. Unable to swallow and retain oral medication.
24. Current use of prohibited medication
25. Participants with laboratory values at screening as defined in the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method