Trial Outcomes & Findings for Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02882321)
NCT ID: NCT02882321
Last Updated: 2023-06-15
Results Overview
Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.03.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1
IACS-010759 Starting dose: 0.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
4
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1
n=4 Participants
IACS-010759 Starting dose: 0.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 Participants
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 Participants
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 Participants
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
56 years
n=7 Participants
|
70 years
n=5 Participants
|
52 years
n=4 Participants
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
17 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysWill be assessed according to National Cancer Institute Common Toxicity Criteria version 4.03.
Outcome measures
| Measure |
Phase I (Cohorts 1-4)
n=17 Participants
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) Defined as the Highest Dose Studied for Which the Observed Incidence of Dose Limiting Toxicities (DLT) is Less Than 33%
|
NA Milligrams (MG)
The study was terminated before determination of Maximum Tolerated Dose (MTD) was determined.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsResponse is Complete Response (CR) + Complete Response with Incomplete Blood Count Recovery (CRi) + Partial Response (PR) + Morphologic Leukemia -Free State (MLFS): CR is Bone marrow blasts \< 5%; absence of circulating blasts and blasts with Auer rods; absence of extra-medullary disease; ANC \> 1.0 x 10\^9/L; platelet count \>/= 100 x 10\^9/L. CRi is CR except for ANC \</= 1.0 x 10\^9 or platelet count , 100 x 10\^9/L. PR is decreased bone marrow blast % by at least 50% to a value of 5% to 25% and ANC \>/= 1.0 x 10\^9/L; platelet count \>/= 100 x 10\^9/L. MLFS is Bone marrow blasts \< 5%; abcence of blasts with Auer rods; absence of extra-medullary disease; no hematologic recovery required.
Outcome measures
| Measure |
Phase I (Cohorts 1-4)
n=4 Participants
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 Participants
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 Participants
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 Participants
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Participants With a Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Zero participants in cohorts 1-4 had a response.
Duration of Response: length of time from the first objective evidence of response to the first objective evidence of disease progression.
Outcome measures
| Measure |
Phase I (Cohorts 1-4)
n=4 Participants
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 Participants
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 Participants
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 Participants
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Duration of Response
|
NA Months
Duration of Response can't be calculated as zero participants had a response.
|
NA Months
Duration of Response can't be calculated as zero participants had a response.
|
NA Months
Duration of Response can't be calculated as zero participants had a response.
|
NA Months
Duration of Response can't be calculated as zero participants had a response.
|
SECONDARY outcome
Timeframe: Up to 5 yearsProgression-Free Survival: length of time (up to 5 years) from the date of first treatment to the first objective evidence of disease progression or death, whichever is earlier.
Outcome measures
| Measure |
Phase I (Cohorts 1-4)
n=4 Participants
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 Participants
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 Participants
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 Participants
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Progression-free Survival
|
1.3 Months
Interval 0.9 to 1.8
|
1.5 Months
Interval 1.5 to 1.7
|
1.4 Months
Interval 1.1 to 2.8
|
0.5 Months
Interval 0.3 to 1.2
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall Survival: length of time from the date of first administration of study drug to the date of death from any cause.
Outcome measures
| Measure |
Phase I (Cohorts 1-4)
n=4 Participants
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 Participants
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 Participants
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 Participants
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Overall Survival
|
NA Months
Median and full range could not be reached due to insufficient number of participants with events.
|
5.6 Months
Interval 2.2 to 8.4
|
2.2 Months
Interval 1.9 to 9.2
|
1.6 Months
Interval 0.4 to 2.6
|
Adverse Events
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
Serious events: 4 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1
n=4 participants at risk
IACS-010759 Starting dose: 0.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 participants at risk
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 participants at risk
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 participants at risk
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
General disorders
Hemorrhage/Bleeding-Other (Specify)
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
28.6%
2/7 • Number of events 2 • Up to 5 years, 6 months
|
|
Infections and infestations
Infection
|
50.0%
2/4 • Number of events 3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
66.7%
2/3 • Number of events 2 • Up to 5 years, 6 months
|
42.9%
3/7 • Number of events 4 • Up to 5 years, 6 months
|
|
Nervous system disorders
Neurology
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/4 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
General disorders
Syndromes
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
Other adverse events
| Measure |
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 1
n=4 participants at risk
IACS-010759 Starting dose: 0.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 2
n=3 participants at risk
IACS-010759 Starting dose: 1 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 3
n=3 participants at risk
IACS-010759 Starting dose: 2 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
Treatment (Oxidative Phosphorylation Inhibitor IACS-010759) Cohort 4
n=7 participants at risk
IACS-010759 Starting dose: 2.5 mg
INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 1-7.
MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.
Oxidative Phosphorylation Inhibitor IACS-010759: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
66.7%
2/3 • Number of events 2 • Up to 5 years, 6 months
|
42.9%
3/7 • Number of events 3 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
Hypoalbumineia
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
hypercalcemia
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Cardiac disorders
Cardiac Arrhythmia
|
75.0%
3/4 • Number of events 3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
General disorders
Constitutional Symptoms
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Investigations
Creatinine
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
28.6%
2/7 • Number of events 2 • Up to 5 years, 6 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Gastrointestinal disorders
xerostomia
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
General disorders
Edema
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulmonary/upper respiratory
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
28.6%
2/7 • Number of events 2 • Up to 5 years, 6 months
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
Magnesium
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-Othe
|
100.0%
4/4 • Number of events 6 • Up to 5 years, 6 months
|
100.0%
3/3 • Number of events 3 • Up to 5 years, 6 months
|
66.7%
2/3 • Number of events 2 • Up to 5 years, 6 months
|
100.0%
7/7 • Number of events 9 • Up to 5 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
66.7%
2/3 • Number of events 2 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
28.6%
2/7 • Number of events 2 • Up to 5 years, 6 months
|
|
Nervous system disorders
Neurology-Other
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Nervous system disorders
Neuropathy: sensory
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Eye disorders
Ocular/Visual-Other
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
General disorders
Pain-Other
|
50.0%
2/4 • Number of events 8 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
28.6%
2/7 • Number of events 5 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
2/4 • Number of events 2 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
General disorders
Syndromes-Other
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Vascular disorders
Thrombosis/embolism
|
25.0%
1/4 • Number of events 1 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/7 • Up to 5 years, 6 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/4 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
0.00%
0/3 • Up to 5 years, 6 months
|
14.3%
1/7 • Number of events 1 • Up to 5 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 6 months
|
42.9%
3/7 • Number of events 3 • Up to 5 years, 6 months
|
Additional Information
Marina Konopleva MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-1628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place