Trial Outcomes & Findings for Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer (NCT NCT01582191)
NCT ID: NCT01582191
Last Updated: 2026-08-28
Results Overview
DLT is defined as any clinically significant grade 3 or 4 non-hematologic toxicity as defined in the NCI-CTCAE v3.0, expected and believed to be related to the study medications, any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE) or associated with bleeding and/or sepsis; Grade 3 to 4 thrombocytopenia lasting 7 days or thrombocytopenia associated with active bleeding or requiring platelet transfusion; Grade 3 nausea/vomiting lasting \> 48 hours or any Grade 4 nausea/vomiting despite maximum anti-nausea regimens (i.e. excluding Grade 3 nausea or Grade 3 to 4 vomiting or diarrhea in patients who had not received optimal antiemetic and anti-diarrheal treatment); and any other clinically significant Grade 3 non-hematologic toxicity including symptoms or signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complications or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
123 participants
Primary outcome timeframe
First 28-day cycle
Results posted on
2026-08-28
Participant Flow
Participant milestones
| Measure |
Escalation Dose Level 0
Vandetinib 100 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 1
Vandetinib 200 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 2
Vandetinib 200 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 3
Vandetinib 300 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 4
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Dose Expansion
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
6
|
6
|
6
|
91
|
|
Overall Study
COMPLETED
|
8
|
5
|
5
|
5
|
5
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
1
|
21
|
Reasons for withdrawal
| Measure |
Escalation Dose Level 0
Vandetinib 100 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 1
Vandetinib 200 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 2
Vandetinib 200 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 3
Vandetinib 300 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 4
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Dose Expansion
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
10
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
8
|
Baseline Characteristics
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
Baseline characteristics by cohort
| Measure |
Escalation Dose Level 0
n=9 Participants
Vandetinib 100 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 1
n=5 Participants
Vandetinib 200 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 2
n=6 Participants
Vandetinib 200 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 3
n=6 Participants
Vandetinib 300 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 4
n=6 Participants
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Dose Expansion
n=91 Participants
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=106 Participants
|
17 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
3 Participants
n=29 Participants
|
4 Participants
n=106 Participants
|
47 Participants
n=6 Participants
|
68 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
3 Participants
n=29 Participants
|
1 Participants
n=106 Participants
|
27 Participants
n=6 Participants
|
37 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
4 Participants
n=29 Participants
|
2 Participants
n=106 Participants
|
50 Participants
n=6 Participants
|
66 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
2 Participants
n=29 Participants
|
4 Participants
n=106 Participants
|
41 Participants
n=6 Participants
|
57 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
24 Participants
n=6 Participants
|
26 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
2 Participants
n=29 Participants
|
3 Participants
n=106 Participants
|
46 Participants
n=6 Participants
|
51 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
4 Participants
n=29 Participants
|
3 Participants
n=106 Participants
|
21 Participants
n=6 Participants
|
46 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
6 Participants
n=29 Participants
|
6 Participants
n=106 Participants
|
70 Participants
n=6 Participants
|
98 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
11 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=31 Participants
|
5 participants
n=49 Participants
|
6 participants
n=80 Participants
|
6 participants
n=29 Participants
|
6 participants
n=106 Participants
|
91 participants
n=6 Participants
|
123 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: First 28-day cycleDLT is defined as any clinically significant grade 3 or 4 non-hematologic toxicity as defined in the NCI-CTCAE v3.0, expected and believed to be related to the study medications, any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE) or associated with bleeding and/or sepsis; Grade 3 to 4 thrombocytopenia lasting 7 days or thrombocytopenia associated with active bleeding or requiring platelet transfusion; Grade 3 nausea/vomiting lasting \> 48 hours or any Grade 4 nausea/vomiting despite maximum anti-nausea regimens (i.e. excluding Grade 3 nausea or Grade 3 to 4 vomiting or diarrhea in patients who had not received optimal antiemetic and anti-diarrheal treatment); and any other clinically significant Grade 3 non-hematologic toxicity including symptoms or signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complications or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
Outcome measures
| Measure |
Escalation Dose Level 0
n=9 Participants
Vandetinib 100 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 1
n=5 Participants
Vandetinib 200 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 2
n=6 Participants
Vandetinib 200 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 3
n=6 Participants
Vandetinib 300 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 4
n=6 Participants
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Dose Expansion
n=91 Participants
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
Adverse Events
Escalation Dose Level 0
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Escalation Dose Level 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Escalation Dose Level 2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Escalation Dose Level 3
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Escalation Dose Level 4
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Expansion
Serious events: 39 serious events
Other events: 67 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Escalation Dose Level 0
n=9 participants at risk
Vandetinib 100 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 1
n=5 participants at risk
Vandetinib 200 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 2
n=6 participants at risk
Vandetinib 200 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 3
n=6 participants at risk
Vandetinib 300 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 4
n=6 participants at risk
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Dose Expansion
n=91 participants at risk
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Musculoskeletal and connective tissue disorders
Lower extremity weakness
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Partial small bowel obstruction
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
33.3%
2/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Renal insufficiency
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
ALT elevation
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Investigations
AST elevation
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
3.3%
3/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Nasuea
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
Hyperbilirubinemia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
General disorders
Weakness
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
3.3%
3/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Mucositis*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Investigations
Elevated lipase
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Investigations
Elevated amylase
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Nervous system disorders
Altered mental status
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Fatigue*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Diarrhea*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Investigations
Thrombocytopenia*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Colitis*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Anasarca
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Blood and lymphatic system disorders
Anemia*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Upper GI bleed*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
Neutrophil count decrease
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Elevated creatinine*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
4.4%
4/91 • Approximately 10.5 years
|
|
Nervous system disorders
Motor neuropathy
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Nervous system disorders
Cranial neuropathy
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Cardiac disorders
Chest pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Vascular disorders
Hypertension*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Cardiac disorders
Atrial flutter*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Cardiac disorders
QTc prolongation*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Fever*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Liver Dysfunction
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Skin and subcutaneous tissue disorders
Rash*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Anxiety
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Insomnia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Swelling
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Cardiac disorders
Heart palpitation*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Failure to thrive
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Cardiac disorders
Pericardial effusion*
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
Other adverse events
| Measure |
Escalation Dose Level 0
n=9 participants at risk
Vandetinib 100 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 1
n=5 participants at risk
Vandetinib 200 mg PO daily Everolimus 2.5 mg PO daily
|
Escalation Dose Level 2
n=6 participants at risk
Vandetinib 200 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 3
n=6 participants at risk
Vandetinib 300 mg PO daily Everolimus 5 mg PO daily
|
Escalation Dose Level 4
n=6 participants at risk
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
Dose Expansion
n=91 participants at risk
Vandetinib 300 mg PO daily Everolimus 10 mg PO daily
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
33.3%
2/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
26.4%
24/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
General disorders
Edema
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Investigations
Weight loss
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
33.3%
2/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
Neutropenia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Investigations
QTc prolongation
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
6.6%
6/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
Transamitis
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Skin and subcutaneous tissue disorders
Hand foot syndrome
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
Leukopenia
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
5.5%
5/91 • Approximately 10.5 years
|
|
Investigations
Alkaline phosphatase increase
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Cardiac disorders
Chest pain
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
7.7%
7/91 • Approximately 10.5 years
|
|
Investigations
Hyperbilirubinemia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Investigations
ALT elevation
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
9.9%
9/91 • Approximately 10.5 years
|
|
Investigations
AST elevation
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
11.0%
10/91 • Approximately 10.5 years
|
|
Investigations
LDH increase
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
6.6%
6/91 • Approximately 10.5 years
|
|
Investigations
Thrombocytopenia
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
33.3%
2/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
14.3%
13/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
50.0%
3/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
12.1%
11/91 • Approximately 10.5 years
|
|
General disorders
Blurry vision
|
11.1%
1/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • Approximately 10.5 years
|
60.0%
3/5 • Approximately 10.5 years
|
50.0%
3/6 • Approximately 10.5 years
|
66.7%
4/6 • Approximately 10.5 years
|
33.3%
2/6 • Approximately 10.5 years
|
36.3%
33/91 • Approximately 10.5 years
|
|
General disorders
Fever
|
0.00%
0/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
General disorders
Anorexia
|
0.00%
0/9 • Approximately 10.5 years
|
40.0%
2/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
15.4%
14/91 • Approximately 10.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/9 • Approximately 10.5 years
|
40.0%
2/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
5.5%
5/91 • Approximately 10.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
0.00%
0/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
2.2%
2/91 • Approximately 10.5 years
|
|
General disorders
Dry lips
|
0.00%
0/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Elevated creatinine
|
11.1%
1/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
9.9%
9/91 • Approximately 10.5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
7.7%
7/91 • Approximately 10.5 years
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
11.0%
10/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
22.2%
2/9 • Approximately 10.5 years
|
20.0%
1/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
9.9%
9/91 • Approximately 10.5 years
|
|
General disorders
Fatigue
|
22.2%
2/9 • Approximately 10.5 years
|
100.0%
5/5 • Approximately 10.5 years
|
33.3%
2/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
50.0%
3/6 • Approximately 10.5 years
|
31.9%
29/91 • Approximately 10.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9 • Approximately 10.5 years
|
40.0%
2/5 • Approximately 10.5 years
|
16.7%
1/6 • Approximately 10.5 years
|
50.0%
3/6 • Approximately 10.5 years
|
50.0%
3/6 • Approximately 10.5 years
|
39.6%
36/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hyperalbuminemia
|
11.1%
1/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/91 • Approximately 10.5 years
|
|
Nervous system disorders
Neuropathy
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
1.1%
1/91 • Approximately 10.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
2/9 • Approximately 10.5 years
|
0.00%
0/5 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
0.00%
0/6 • Approximately 10.5 years
|
5.5%
5/91 • Approximately 10.5 years
|
Additional Information
Sarina Anne Piha-Paul, MD
The University of Texas MD Anderson Cancer Center
Phone: (713) 563-1055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place