Trial Outcomes & Findings for INCB018424 in Patients With Advanced Hematologic Malignancies (NCT NCT00674479)
NCT ID: NCT00674479
Last Updated: 2025-06-15
Results Overview
"Time of Response " defined as the period of time from the date of first study drug administration until the first objective documentation of response. Clinical response is defined as Complete remission (CR) + Partial remission (PR) + CRp + Hematologic Improvement (HI). Participants in CR must be free of all symptoms related to leukemia and have an absolute neutrophil count (ANC) \>/= 1x10\^9/L, platelet count ./+ 100x10\^9, normal marrow differential (\</= 5% blasts). Partial remission (PR) is CR with 6-25% abnormal cells in the marrow or 50% decrease in marrow blasts. CRp is CR but platelet count \< 100x10\^9/L. HI is defined as for patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.
COMPLETED
PHASE2
51 participants
Patients will be evaluated after each full cycle of therapy (28 days) for response.
2025-06-15
Participant Flow
51 participants received study medication.
Participant milestones
| Measure |
INCB018424
The starting dose of INCB018424 will be 25 mg by mouth twice daily.
INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INCB018424 in Patients With Advanced Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
INCB018424
n=51 Participants
The starting dose of INCB018424 will be 25 mg by mouth twice daily.
INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=99 Participants
|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Patients will be evaluated after each full cycle of therapy (28 days) for response."Time of Response " defined as the period of time from the date of first study drug administration until the first objective documentation of response. Clinical response is defined as Complete remission (CR) + Partial remission (PR) + CRp + Hematologic Improvement (HI). Participants in CR must be free of all symptoms related to leukemia and have an absolute neutrophil count (ANC) \>/= 1x10\^9/L, platelet count ./+ 100x10\^9, normal marrow differential (\</= 5% blasts). Partial remission (PR) is CR with 6-25% abnormal cells in the marrow or 50% decrease in marrow blasts. CRp is CR but platelet count \< 100x10\^9/L. HI is defined as for patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.
Outcome measures
| Measure |
INCB018424
n=51 Participants
The starting dose of INCB018424 will be 25 mg by mouth twice daily.
INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks.
|
|---|---|
|
Response Rate
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: INCB018424 PK profile was not done because there was no historical data to compare it to. Data for this Outcome were not collected.
Exploratory sampling will be done to determine the INCB018424 PK profile. The PK parameters of INB018424 will be summarized using descriptive statistics, and the log-transformed INCB018424 PK parameters will be compared using a 1-factor analysis of variance. The mean values of the PK parameters may be compared to historical data in healthy volunteers to determine if the INCB018424 PK profile is different between patients with hematological malignancies and healthy patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 monthsPopulation: The lab data was not collected so the analysis could not be done.
The PD parameters will be calculated to explore preliminary evidence of PD activity by assessing the effect of INCB018424 on pre- and post-dose. If the p-STAT3/5 signaling data are sufficiently robust, an exploratory PK/PD analysis will be performed.
Outcome measures
Outcome data not reported
Adverse Events
INCB018424
Serious adverse events
| Measure |
INCB018424
n=51 participants at risk
The starting dose of INCB018424 will be 25 mg by mouth twice daily.
INCB018424: Starting dose: 25 mg by mouth (po) twice daily for 7 days each week for 4 weeks.
|
|---|---|
|
Cardiac disorders
Cerebrovascular Accident
|
2.0%
1/51 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
General disorders
Death
|
11.8%
6/51 • Number of events 6 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Infections and infestations
Neutropenic Fever
|
7.8%
4/51 • Number of events 5 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
General disorders
Fever
|
3.9%
2/51 • Number of events 3 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Vascular disorders
Left Basilic Vein Thrombus
|
2.0%
1/51 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.0%
1/51 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage CNS
|
2.0%
1/51 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Infections and infestations
Infection
|
5.9%
3/51 • Number of events 3 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
General disorders
Fall
|
2.0%
1/51 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Infections and infestations
Pneumonia
|
7.8%
4/51 • Number of events 4 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Infections and infestations
Sepsis
|
3.9%
2/51 • Number of events 2 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Joint-Effusion
|
2.0%
1/51 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 5 years.
|
Other adverse events
Adverse event data not reported
Additional Information
Farhad Ravandi-Kashani, MD/Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place