Trial Outcomes & Findings for Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers (NCT NCT04462471)
NCT ID: NCT04462471
Last Updated: 2025-09-08
Results Overview
The primary objective of this study is to determine the MTD of vemurafenib plus copanlisib inpatients with advanced BRAF mutant RAIR thyroid cancer. The MTD is defined as the highest dose at which no more than 1 of 6 patients treated at that dose experience a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-08
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Dose Level 1: Vemurafenib 960mg, Copanlisib 45mg
|
Dose Level 2
Dose Level 2: Vemurafenib 960mg, Copanlisib 60mg
|
Dose Level -1
Dose Level -1: Vemurafenib 720mg, Copanlisib 45mg
|
Dose Level -2
Dose Level -2: Vemurafenib 480mg, Copanlisib 45mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
Dose Level 1: Vemurafenib 960mg, Copanlisib 45mg
|
Dose Level 2
Dose Level 2: Vemurafenib 960mg, Copanlisib 60mg
|
Dose Level -1
Dose Level -1: Vemurafenib 720mg, Copanlisib 45mg
|
Dose Level -2
Dose Level -2: Vemurafenib 480mg, Copanlisib 45mg
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease progression
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=4 Participants
Dose Level 1: Vemurafenib 960mg, Copanlisib 45mg
|
Dose Level 2
n=4 Participants
Dose Level 2: Vemurafenib 960mg, Copanlisib 60mg
|
Dose Level -1
Dose Level -1: Vemurafenib 720mg, Copanlisib 45mg
|
Dose Level -2
Dose Level -2: Vemurafenib 480mg, Copanlisib 45mg
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
54 years
n=107 Participants
|
—
|
—
|
55 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
—
|
2 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
—
|
—
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
—
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
—
|
—
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
—
|
—
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
—
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
—
|
—
|
8 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Study closed to low accrual
The primary objective of this study is to determine the MTD of vemurafenib plus copanlisib inpatients with advanced BRAF mutant RAIR thyroid cancer. The MTD is defined as the highest dose at which no more than 1 of 6 patients treated at that dose experience a DLT.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Dose Level 1: Vemurafenib 960mg, Copanlisib 45mg
|
Dose Level 2
n=4 Participants
Dose Level 2: Vemurafenib 960mg, Copanlisib 60mg
|
Dose Level -1
Dose Level -1: Vemurafenib 720mg, Copanlisib 45mg
|
Dose Level -2
Dose Level -2: Vemurafenib 480mg, Copanlisib 45mg
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Experienced DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Did not experience DLT
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Level -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level -2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Dose Level 1: Vemurafenib 960mg, Copanlisib 45mg
|
Dose Level 2
n=4 participants at risk
Dose Level 2: Vemurafenib 960mg, Copanlisib 60mg
|
Dose Level -1
Dose Level -1: Vemurafenib 720mg, Copanlisib 45mg
|
Dose Level -2
Dose Level -2: Vemurafenib 480mg, Copanlisib 45mg
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
General disorders
Fever
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
Other adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Dose Level 1: Vemurafenib 960mg, Copanlisib 45mg
|
Dose Level 2
n=4 participants at risk
Dose Level 2: Vemurafenib 960mg, Copanlisib 60mg
|
Dose Level -1
Dose Level -1: Vemurafenib 720mg, Copanlisib 45mg
|
Dose Level -2
Dose Level -2: Vemurafenib 480mg, Copanlisib 45mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
75.0%
3/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
75.0%
3/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Dysgeusia
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
General disorders
Fatigue
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
50.0%
2/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
General disorders
Fever
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Metabolism and nutrition disorders
Hypertension
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Lipase increased
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
50.0%
2/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
25.0%
1/4 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
—
0/0 • 1 year
Participants were not treated on Dose Level -1 or Dose Level -2
|
Additional Information
Dr. Alan Ho, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place