Trial Outcomes & Findings for PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery (NCT NCT03218826)
NCT ID: NCT03218826
Last Updated: 2025-10-30
Results Overview
The number of DLTs at each dose level will determine the MTD or RP2D of PI3Kbeta inhibitor AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
At Day 22
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
5
|
4
|
7
|
|
Overall Study
COMPLETED
|
5
|
1
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dose Level 1
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Non-compliance with protocol
|
1
|
0
|
2
|
1
|
1
|
Baseline Characteristics
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=6 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=5 Participants
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=4 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=7 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
56 years
n=7 Participants
|
55 years
n=5 Participants
|
56 years
n=4 Participants
|
61 years
n=21 Participants
|
56 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
21 Participants
n=8 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
7 participants
n=21 Participants
|
23 participants
n=8 Participants
|
|
Height
|
168.5 centimeter (cm)
n=5 Participants
|
183 centimeter (cm)
n=7 Participants
|
170 centimeter (cm)
n=5 Participants
|
160.5 centimeter (cm)
n=4 Participants
|
170 centimeter (cm)
n=21 Participants
|
168 centimeter (cm)
n=8 Participants
|
|
Weight
|
79.5 kilogram (kg)
n=5 Participants
|
100 kilogram (kg)
n=7 Participants
|
58.6 kilogram (kg)
n=5 Participants
|
68 kilogram (kg)
n=4 Participants
|
77.9 kilogram (kg)
n=21 Participants
|
76.2 kilogram (kg)
n=8 Participants
|
|
Body Surface Area
|
1.86 meters squared (m^2)
n=5 Participants
|
2.22 meters squared (m^2)
n=7 Participants
|
1.68 meters squared (m^2)
n=5 Participants
|
1.73 meters squared (m^2)
n=4 Participants
|
1.94 meters squared (m^2)
n=21 Participants
|
1.90 meters squared (m^2)
n=8 Participants
|
PRIMARY outcome
Timeframe: At Day 22The number of DLTs at each dose level will determine the MTD or RP2D of PI3Kbeta inhibitor AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors.
Outcome measures
| Measure |
Dose Level 1
n=5 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=3 Participants
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=3 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=6 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Experienced Dose Limiting Toxicity
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Did not experience Dose Limiting Toxicity
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPatient safety and tolerability will be described according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version for routine toxicity reporting and CTCAE, version 5 for serious adverse events only.
Outcome measures
| Measure |
Dose Level 1
n=5 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=3 Participants
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=3 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=6 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Grades 3-5
Experienced AEs grades 3-5
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) Grades 3-5
Not Experienced AEs grades 3-5
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 24 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. For participants with prostate cancer who do not have sites of disease on imaging, objective response is the reduction of prostate specific antigen (PSA) level of 50% or more.
Outcome measures
| Measure |
Dose Level 1
n=5 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=3 Participants
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=3 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=6 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
Objective response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate (ORR)
No objective response
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Objective Response Rate (ORR)
Not assessed
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 24 weeksWill be assessed by modified Response Evaluation Criteria in Solid Tumors version 1.1. Will assess the CBR of PI3Kbeta inhibitor AZD8186 when administered in combination with docetaxel in patients with PTEN or PIK3CB mutated advanced solid tumors. A 90% confidence interval on CBR will be calculated assuming binomial proportions.
Outcome measures
| Measure |
Dose Level 1
n=5 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=3 Participants
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=3 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=6 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) Defined as Complete Response (CR), Partial Response (PR), or Stable Disease
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Benefit Rate (CBR) Defined as Complete Response (CR), Partial Response (PR), or Stable Disease
Partial Response (PR)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Benefit Rate (CBR) Defined as Complete Response (CR), Partial Response (PR), or Stable Disease
Stable Disease (SD)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Benefit Rate (CBR) Defined as Complete Response (CR), Partial Response (PR), or Stable Disease
Progressive Disease (PD)
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Clinical Benefit Rate (CBR) Defined as Complete Response (CR), Partial Response (PR), or Stable Disease
Not assessed
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 hours after initial treatmentPopulation: Test not collected for pts on dose level -1.
Will investigate the concentration of docetaxel in the blood when participants also take the PI3Kbeta inhibitor AZD8186. Blood is drawn after docetaxel infusion and before the participant takes AZD8186, after the participant takes AZD8186, and again 6 hours after taking AZD8186. Blood concentrations of docetaxel are measured at each collection time. The change in concentrations at the different dose levels may suggest whether AZD8186 impacts how much docetaxel is still in the blood over time.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=1 Participants
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=3 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=6 Participants
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Maximum Blood Concentrations of Docetaxel When Also Taking AZD8186
Pre-Treatment
|
3083.3 ng/ml
Standard Deviation 1933.8
|
—
|
2060.0 ng/ml
Standard Deviation 0
|
3280.0 ng/ml
Standard Deviation 585.1
|
3450.0 ng/ml
Standard Deviation 1735.9
|
|
Maximum Blood Concentrations of Docetaxel When Also Taking AZD8186
After Treatment
|
6981.7 ng/ml
Standard Deviation 4457.9
|
—
|
3615.0 ng/ml
Standard Deviation 0
|
4728.6 ng/ml
Standard Deviation 0
|
6493.9 ng/ml
Standard Deviation 3437.8
|
|
Maximum Blood Concentrations of Docetaxel When Also Taking AZD8186
6 Hours after Treatment
|
6213.8 ng/ml
Standard Deviation 3991.4
|
—
|
3056.1 ng/ml
Standard Deviation 0
|
4411.6 ng/ml
Standard Deviation 0
|
7008.0 ng/ml
Standard Deviation 3877.0
|
Adverse Events
Dose Level 1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Dose Level -1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level -1B
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Dose Level 1 With Growth Factors
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level 1
n=6 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=5 participants at risk
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=4 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=7 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
General disorders
disease progression
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
40.0%
2/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Psychiatric disorders
Delirium
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
Other adverse events
| Measure |
Dose Level 1
n=6 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 30 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1B
n=5 participants at risk
Patients receive docetaxel 60 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1 With Growth Factors
n=4 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 60 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=7 participants at risk
Patients receive docetaxel 75 mg/m\^2 IV over 1 hour on day 1 and PI3Kbeta inhibitor AZD8186 120 mg PO BID for 5 days each week. Cycles repeat every 21 days until April 30, 2022 in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
3/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
40.0%
2/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Blood and lymphatic system disorders
ALT level increased
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
80.0%
4/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
40.0%
2/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
General disorders
Chills
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
40.0%
2/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
71.4%
5/7 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
General disorders
Edema limbs
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Eye disorders
Eye twitching
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
General disorders
Fatigue
|
83.3%
5/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Finger Cramping
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
General disorders
Flu like symptoms
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
60.0%
3/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
General disorders
Localized edema
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
60.0%
3/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
42.9%
3/7 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
nail changes
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail Lifting
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
50.0%
2/4 • Up to 3 years
|
57.1%
4/7 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
60.0%
3/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
General disorders
Pain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Renal and urinary disorders
Prolapsed Bladder
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Surgical and medical procedures
Root canal procedure
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
40.0%
2/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Infections and infestations
Thrush
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Toe nail changes
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Gastrointestinal disorders
Tooth pain / Swelling
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
28.6%
2/7 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
16.7%
1/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Investigations
Weight gain
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
0.00%
0/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
|
Investigations
Weight loss
|
0.00%
0/6 • Up to 3 years
|
0.00%
0/1 • Up to 3 years
|
20.0%
1/5 • Up to 3 years
|
25.0%
1/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Up to 3 years
|
100.0%
1/1 • Up to 3 years
|
60.0%
3/5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Up to 3 years
|
Additional Information
Grants Administrative Manager
Johns Hopkins University/SKCCC
Phone: 4439273568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60