Trial Outcomes & Findings for Trametinib With GSK2141795 in BRAF Wild-type Melanoma (NCT NCT01941927)
NCT ID: NCT01941927
Last Updated: 2020-02-12
Results Overview
Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response These participants will have their response classified according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) method, where the baseline target lesion sum of longest diameter (LD) will be used as reference by which to characterize the objective tumor response. An objective response is defined as an overall response of complete response (CR), partial response (PR), or stable disease (SD) with a confirmatory scan or evaluation at time of final disease response determination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 2 years from beginning of therapy
Results posted on
2020-02-12
Participant Flow
Participant milestones
| Measure |
NRAS Wildtype
Patients without NRAS (neuroblastoma RAS viral oncogene homolog) exon 1 and 2 mutations
|
NRAS Mutant
Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trametinib With GSK2141795 in BRAF Wild-type Melanoma
Baseline characteristics by cohort
| Measure |
NRAS Wildtype
n=10 Participants
Patients without NRAS exon 1 and 2 mutations
|
NRAS Mutant
n=10 Participants
Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
59.3 years
n=5 Participants
|
56.8 years
n=7 Participants
|
58.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status: 0
ECOG status 0
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status: 0
ECOG status 1
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status: 0
ECOG status 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Stage
M1a
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Stage
M1b
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Stage
M1c
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH) level
LDH normal
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH) level
LDH elevated
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Genotype
Genotype NRAS Q61H
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Genotype
Genotype NRAS Q61K
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Genotype
Genotype NRAS Q61L
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Genotype
Genotype NRAS Q61R
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Genotype
BRAF Wild Type (WT) /NRAS WT
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Subtype
Cutaneous
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Subtype
Mucosal
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Subtype
Acral
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Subtype
Uveal
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years from beginning of therapyPopulation: Reported here are a number of participants that achieved the best objective response defined as stable disease
Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response These participants will have their response classified according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) method, where the baseline target lesion sum of longest diameter (LD) will be used as reference by which to characterize the objective tumor response. An objective response is defined as an overall response of complete response (CR), partial response (PR), or stable disease (SD) with a confirmatory scan or evaluation at time of final disease response determination.
Outcome measures
| Measure |
NRAS Wildtype
n=10 Participants
Patients without NRAS exon 1 and 2 mutations
|
NRAS Mutant
n=10 Participants
Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
|
|---|---|---|
|
Objective Response Rate (ORR)
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years from beginning of therapyTime from randomization to objective tumor progression or death. Participants who die without documentation of disease progression and before it was time to conduct the first tumor reassessment, will be considered inevaluable or not assessed adequately
Outcome measures
| Measure |
NRAS Wildtype
n=10 Participants
Patients without NRAS exon 1 and 2 mutations
|
NRAS Mutant
n=10 Participants
Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
|
|---|---|---|
|
Progression-Free Survival of Patients Treated With the Combination of Trametinib and GSK 2141795
|
2.8 months
Interval 2.6 to 2.9
|
2.3 months
Interval 2.1 to 2.5
|
SECONDARY outcome
Timeframe: Up to 2 years from beginning of therapyOutcome measures
| Measure |
NRAS Wildtype
n=10 Participants
Patients without NRAS exon 1 and 2 mutations
|
NRAS Mutant
n=10 Participants
Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
|
|---|---|---|
|
Overall Survival of Patients Treated With the Combination of Trametinib and GSK 2141795
|
3.5 months
Interval 0.6 to 6.4
|
4 months
Interval 0.9 to 7.0
|
SECONDARY outcome
Timeframe: Up to 2 years from beginning of therapyPopulation: The drug combination failed to produce objective responses in participants with either NRAS mutant or NRAS wild-type melanoma in TTP evaluable patient population. No objective responses for progression in TTP specific evaluable participants population were observed so endpoint could not be calculated.
Time from treatment initiation until objective tumor progression observed. Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. Participants who exhibit objective disease progression prior to the end of Cycle 1 will be considered evaluable. Response will also be considered inevaluable for any participants receiving treatment (regardless of how much was received) who did not have any follow-up assessment completed before initiation of alternative treatment or participants who die without documentation of disease progression and before it was time to conduct the first tumor reassessment, will be considered inevaluable or not assessed adequately
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years from beginning of therapyOutcome measures
| Measure |
NRAS Wildtype
n=10 Participants
Patients without NRAS exon 1 and 2 mutations
|
NRAS Mutant
Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing
|
|---|---|---|
|
Number of Severe Adverse Events (Grade 3 and 4) Reported by Patients Related With the Treatment of Trametinib and GSK2141795.
|
6 Severe Adverse Events
|
—
|
Adverse Events
Trametinib, GSK2141795
Serious events: 5 serious events
Other events: 17 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Trametinib, GSK2141795
n=20 participants at risk
Trametinib (GSK1120212)
* Oral, 2 mg Daily
* Number of Cycles: until progression or unacceptable toxicity develops
GSK2141795
* Oral, 25 mg Daily
* Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
General disorders
failure to thrive
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Infections and infestations
decubitus ulcer
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
Other adverse events
| Measure |
Trametinib, GSK2141795
n=20 participants at risk
Trametinib (GSK1120212)
* Oral, 2 mg Daily
* Number of Cycles: until progression or unacceptable toxicity develops
GSK2141795
* Oral, 25 mg Daily
* Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
12/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Mucositis oral
|
15.0%
3/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Anal fistula
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
30.0%
6/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
5/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
General disorders
Fatigue
|
20.0%
4/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
General disorders
Fever
|
15.0%
3/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
General disorders
Chills
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
General disorders
Malaise
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Nervous system disorders
Sinus pain
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Infections and infestations
Rash pustular
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Infections and infestations
Bladder infection
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.0%
1/20 • Patient toxicity will be collected from time of first treatment at weekly scheduled study visits. Patients will be followed for toxicity for 30 days after last dose of study drug or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed additionally until resolution or stabilization of all treatment related adverse events to Grade 2 or lower
|
Additional Information
Adil Daud, MD
University of California, San Francisco
Phone: (415) 353-7392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place