Trial Outcomes & Findings for A Study of the Hsp90 Inhibitor AUY922 Plus Capecitabine for the Treatment of Patients With Advanced Solid Tumors (NCT NCT01226732)
NCT ID: NCT01226732
Last Updated: 2022-03-08
Results Overview
To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
18 months
Results posted on
2022-03-08
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 2
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
5
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
5
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Hsp90 Inhibitor AUY922 Plus Capecitabine for the Treatment of Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 2
n=3 Participants
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
n=3 Participants
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
n=5 Participants
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
n=3 Participants
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
n=6 Participants
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
51 years
n=7 Participants
|
64 years
n=5 Participants
|
60 years
n=4 Participants
|
58 years
n=21 Participants
|
65.5 years
n=8 Participants
|
60 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=8 Participants
|
23 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 18 monthsTo determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.
Outcome measures
| Measure |
All Patients
n=23 Participants
The Maximum Tolerated Dose (MTD) is determined for all patients
|
Dose Level 2
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
|---|---|---|---|---|---|---|
|
Dose Determination
AUY922 dose
|
70 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
|
Dose Determination
Capecitabine dose
|
1250 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsTo evaluate the drug related toxicities associated with different doses of the drugs used in this regimen.
Outcome measures
| Measure |
All Patients
n=3 Participants
The Maximum Tolerated Dose (MTD) is determined for all patients
|
Dose Level 2
n=3 Participants
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
n=3 Participants
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
n=5 Participants
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
n=3 Participants
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
n=6 Participants
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
|---|---|---|---|---|---|---|
|
Drug Related Toxicities
Diarrhea
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
3 participants
|
4 participants
|
|
Drug Related Toxicities
Vision changes
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
3 participants
|
6 participants
|
|
Drug Related Toxicities
Fatigue
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
|
Drug Related Toxicities
Nausea
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Drug Related Toxicities
Hand-foot syndrome
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
5 participants
|
|
Drug Related Toxicities
Anorexia
|
2 participants
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Drug Related Toxicities
Vomiting
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Includes all patients evaluable for response. 4 patients were not evaluable: dose level 2 (1 pt), dose level 4 (2 pts), dose level 6 (1 pt).
Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
All Patients
n=3 Participants
The Maximum Tolerated Dose (MTD) is determined for all patients
|
Dose Level 2
n=2 Participants
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
n=3 Participants
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
n=3 Participants
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
n=3 Participants
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
n=5 Participants
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
|---|---|---|---|---|---|---|
|
Preliminary Efficacy Assessment: Response Rate (RR)
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 4
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Level 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 6
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 2
n=3 participants at risk
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
n=3 participants at risk
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
n=5 participants at risk
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
n=3 participants at risk
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
n=6 participants at risk
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
|---|---|---|---|---|---|---|
|
General disorders
General disorders and administration site conditions - Other, failure to thrive
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/6 • 18 months
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 2
n=3 participants at risk
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 3
n=3 participants at risk
Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 4
n=5 participants at risk
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 5
n=3 participants at risk
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
Dose Level 6
n=6 participants at risk
Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.
Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 18 months
|
33.3%
1/3 • 18 months
|
66.7%
2/3 • 18 months
|
80.0%
4/5 • 18 months
|
66.7%
2/3 • 18 months
|
83.3%
5/6 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 18 months
|
66.7%
2/3 • 18 months
|
33.3%
1/3 • 18 months
|
100.0%
5/5 • 18 months
|
66.7%
2/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
60.0%
3/5 • 18 months
|
33.3%
1/3 • 18 months
|
66.7%
4/6 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
80.0%
4/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
40.0%
2/5 • 18 months
|
33.3%
1/3 • 18 months
|
83.3%
5/6 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
1/3 • 18 months
|
40.0%
2/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
20.0%
1/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Eye disorders
Eye disorders - Other, vision changes
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
20.0%
1/5 • 18 months
|
66.7%
2/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
66.7%
2/3 • 18 months
|
50.0%
3/6 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
50.0%
3/6 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
50.0%
3/6 • 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 18 months
|
66.7%
2/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
66.7%
2/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
20.0%
1/5 • 18 months
|
33.3%
1/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
66.7%
2/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
General disorders
Edema limbs
|
66.7%
2/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Eye disorders
Floaters
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
66.7%
2/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
40.0%
2/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
40.0%
2/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Investigations
Weight loss
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Eye disorders
Flashing lights
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
40.0%
2/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, skin changes
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
40.0%
2/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Eye disorders
Eye disorders - Other, color differentiation difficulties
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
2/6 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
16.7%
1/6 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 18 months
|
33.3%
1/3 • 18 months
|
0.00%
0/3 • 18 months
|
20.0%
1/5 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/6 • 18 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/3 • 18 months
|
0.00%
0/5 • 18 months
|
0.00%
0/3 • 18 months
|
33.3%
2/6 • 18 months
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER