Trial Outcomes & Findings for BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer (NCT NCT01870505)
NCT ID: NCT01870505
Last Updated: 2024-12-09
Results Overview
Participants started BYL719 dose of 300mg daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719. All participants within a cohort will be observed for toxicity for one cycle (28 days) prior to entering additional patients.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
28 days (1 Cycle)
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
DOSE FINDING PHASE, Arm A, Cohort 0
DOSE FINDING PHASE, Arm A, Cohort 0: BYL719 300mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm A, Cohort -1
DOSE FINDING PHASE, Arm A, Cohort -1: BYL719 250 mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm B, Cohort 0
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
7
|
10
|
6
|
6
|
3
|
6
|
7
|
|
Overall Study
COMPLETED
|
4
|
3
|
7
|
10
|
6
|
6
|
3
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
DOSE FINDING PHASE, Arm A, Cohort 0
n=4 Participants
Period 1: DOSE FINDING PHASE, Arm A, Cohort 0: BYL719 300mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm A, Cohort -1
n=3 Participants
Period 2: DOSE FINDING PHASE, Arm A, Cohort -1: BYL719 250 mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm B, Cohort 0
n=7 Participants
Period 1: DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
n=10 Participants
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
n=6 Participants
Period 1: Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
n=6 Participants
Period 2: Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
n=3 Participants
Period 1: Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
n=6 Participants
Period 2: Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
n=7 Participants
Period 3: Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
48 years
n=7 Participants
|
50 years
n=5 Participants
|
52 years
n=4 Participants
|
55 years
n=21 Participants
|
62 years
n=8 Participants
|
52 years
n=8 Participants
|
57 years
n=24 Participants
|
58 years
n=42 Participants
|
55 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
40 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 28 days (1 Cycle)Participants started BYL719 dose of 300mg daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719. All participants within a cohort will be observed for toxicity for one cycle (28 days) prior to entering additional patients.
Outcome measures
| Measure |
Arm A: BYL719 Plus Letrozole
n=7 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Letrozole
|
Arm B: BYL719 Plus Exemestane
n=7 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Exemestane
|
Arm C: BYL719 Plus Letrozole
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase II Dose of BYL719/Alpelisib (Arm A and Arm B)
|
250 mg
|
250 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days (1 cycle)Participants started BYL719 dose of 250 daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719.
Outcome measures
| Measure |
Arm A: BYL719 Plus Letrozole
n=12 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Letrozole
|
Arm B: BYL719 Plus Exemestane
n=26 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Exemestane
|
Arm C: BYL719 Plus Letrozole
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase II Dose of BYL719 (Arm C and Arm D)
|
250 mg
|
350 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (1 cycle)Toxicity will be tabulated using the NCI Common Toxicity Criteria (CTCAE), version 4.0. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, meeting any of the criteria listed in the table below, and occurring during Cycle 1 (≤ 28 days following the first dose of BYL719, including those in which the event started in Cycle 1 and the confirmation of the DLT occurs in a subsequent cycle).
Outcome measures
| Measure |
Arm A: BYL719 Plus Letrozole
n=4 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Letrozole
|
Arm B: BYL719 Plus Exemestane
n=3 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Exemestane
|
Arm C: BYL719 Plus Letrozole
n=7 Participants
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
n=10 Participants
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
n=6 Participants
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
n=6 Participants
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
n=3 Participants
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
n=6 Participants
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
n=7 Participants
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Evaluated for Safety and Tolerability of BYL719 (Arm A, B, C and D)
|
4 Participants
|
3 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall response rate
Outcome measures
| Measure |
Arm A: BYL719 Plus Letrozole
n=7 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Letrozole
|
Arm B: BYL719 Plus Exemestane
n=7 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Exemestane
|
Arm C: BYL719 Plus Letrozole
n=12 Participants
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
n=26 Participants
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Partial Response (PR)
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Stable Disease (SD)
|
4 Participants
|
3 Participants
|
6 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Progression of Disease (POD)
|
0 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Unevaluable
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through study completion, an average of 3.5 yearsTime to Treatment Failure/TTF defined as the time from on-study date to off-study date for any reason
Outcome measures
| Measure |
Arm A: BYL719 Plus Letrozole
n=7 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Letrozole
|
Arm B: BYL719 Plus Exemestane
n=7 Participants
For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter.
BYL719
Exemestane
|
Arm C: BYL719 Plus Letrozole
n=12 Participants
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
n=26 Participants
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Time to Treatment Failure/TTF
|
21 weeks
Interval 2.0 to 169.0
|
8 weeks
Interval 2.0 to 29.0
|
12 weeks
Interval 3.0 to 72.0
|
17 weeks
Interval 3.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
DOSE FINDING PHASE, Arm A, Cohort 0
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
DOSE FINDING PHASE, Arm A, Cohort -1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DOSE FINDING PHASE, Arm B, Cohort 0
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Arm D
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Dose Finding Phase, Arm C, Cohort 0
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Finding Phase, Arm C, Cohort 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Finding Phase, Arm D, Cohort 0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Finding Phase, Arm D, Cohort 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Finding Phase, Arm D, Cohort 2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DOSE FINDING PHASE, Arm A, Cohort 0
n=4 participants at risk
DOSE FINDING PHASE, Arm A, Cohort 0: BYL719 300mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm A, Cohort -1
n=3 participants at risk
DOSE FINDING PHASE, Arm A, Cohort -1: BYL719 250 mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm B, Cohort 0
n=7 participants at risk
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
n=10 participants at risk
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
n=6 participants at risk
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
n=6 participants at risk
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
n=3 participants at risk
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
n=6 participants at risk
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
n=7 participants at risk
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
28.6%
2/7 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
General disorders
Death NOS
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
28.6%
2/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
General disorders
Fever
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Infections and infestations
Joint infection
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
Other adverse events
| Measure |
DOSE FINDING PHASE, Arm A, Cohort 0
n=4 participants at risk
DOSE FINDING PHASE, Arm A, Cohort 0: BYL719 300mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm A, Cohort -1
n=3 participants at risk
DOSE FINDING PHASE, Arm A, Cohort -1: BYL719 250 mg PO, Letrozole 2.5mg PO
|
DOSE FINDING PHASE, Arm B, Cohort 0
n=7 participants at risk
DOSE FINDING PHASE, Arm B, Cohort 0: BYL719 300mg PO, Exemestane 25mg PO
|
Arm D
n=10 participants at risk
Arm D : Exemestane 25 mg PO + BYL719 MTD: 350mg PO
|
Dose Finding Phase, Arm C, Cohort 0
n=6 participants at risk
Dose Finding Phase, Arm C, Cohort 0: Letrozole 2.5mg PO daily \& BYL719 250 mg 7days on and 7days off.
|
Dose Finding Phase, Arm C, Cohort 1
n=6 participants at risk
Dose Finding Phase, Arm C, Cohort 1: Letrozole 2.5mg PO daily \& BYL719 300 mg 7days on and 7days off.
|
Dose Finding Phase, Arm D, Cohort 0
n=3 participants at risk
Dose Finding Phase, Arm D, Cohort 0: Exemestane 25mg PO daily \& BYL719 250 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 1
n=6 participants at risk
Dose Finding Phase, Arm D, Cohort 1: Exemestane 25mg PO daily \& BYL719 300 mg 5days on and 2days off.
|
Dose Finding Phase, Arm D, Cohort 2
n=7 participants at risk
Dose Finding Phase, Arm D, Cohort 2: Exemestane 25mg PO daily \& BYL719 350 mg 5days on and 2days off.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
1/6 • 2 years
|
28.6%
2/7 • 2 years
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
20.0%
2/10 • 2 years
|
16.7%
1/6 • 2 years
|
33.3%
2/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
42.9%
3/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • 2 years
|
33.3%
1/3 • 2 years
|
14.3%
1/7 • 2 years
|
20.0%
2/10 • 2 years
|
33.3%
2/6 • 2 years
|
33.3%
2/6 • 2 years
|
0.00%
0/3 • 2 years
|
33.3%
2/6 • 2 years
|
28.6%
2/7 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
28.6%
2/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
33.3%
2/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
1/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
28.6%
2/7 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
14.3%
1/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
16.7%
1/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
42.9%
3/7 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
42.9%
3/7 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
20.0%
2/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Investigations
Lipase increased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
General disorders
Pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
10.0%
1/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
1/6 • 2 years
|
0.00%
0/7 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
1/6 • 2 years
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/10 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/6 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
14.3%
1/7 • 2 years
|
Additional Information
Dr. Sarat Chandarlapaty, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place