Trial Outcomes & Findings for Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma (NCT NCT01120275)
NCT ID: NCT01120275
Last Updated: 2016-06-14
Results Overview
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Disease assessments were performed every 6 weeks, up to 3 years.
Results posted on
2016-06-14
Participant Flow
Participant milestones
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
Eligible and Treated
|
32
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Progression
|
27
|
|
Overall Study
Ineligible
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Refusal
|
1
|
|
Overall Study
Not specific
|
1
|
Baseline Characteristics
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
n=32 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
60.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Performance Status
0
|
24 participants
n=5 Participants
|
|
Performance Status
1
|
8 participants
n=5 Participants
|
|
Primary Type
Cutaneous
|
22 participants
n=5 Participants
|
|
Primary Type
Unknown primary
|
10 participants
n=5 Participants
|
|
Site(s) of Metastases
Bone
|
8 participants
n=5 Participants
|
|
Site(s) of Metastases
Liver
|
12 participants
n=5 Participants
|
|
Site(s) of Metastases
Lymph node, skin, soft tissue
|
17 participants
n=5 Participants
|
|
Site(s) of Metastases
Lung
|
17 participants
n=5 Participants
|
|
Site(s) of Metastases
Other non-visceral
|
1 participants
n=5 Participants
|
|
Site(s) of Metastases
Other visceral
|
9 participants
n=5 Participants
|
|
Elevated Lactate Dehydrogenase (LDH)
No
|
19 participants
n=5 Participants
|
|
Elevated Lactate Dehydrogenase (LDH)
Yes
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease assessments were performed every 6 weeks, up to 3 years.From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.
Outcome measures
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
n=32 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
1.5 Months
Interval 1.3 to 2.6
|
PRIMARY outcome
Timeframe: Weekly, up to 3 years.From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
n=32 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
13 Months
Interval 8.0 to 20.0
|
SECONDARY outcome
Timeframe: Disease assessments for response were performed every 6 weeks, up to 3 yearsComplete disappearance of all measurable and non-measurable disease, or greater than or equal to 30% decrease under baseline of the sum of the longest diameters of all target measurable lesions.
Outcome measures
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
n=32 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response
|
0.03 portation of participants
Interval 0.0 to 0.16
|
SECONDARY outcome
Timeframe: Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 yearsPopulation: Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by CTCAE version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Treatment (Gamma-secretase Inhibitor RO4929097)
n=32 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Electrocardiogram QT corrected interval prolonged
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain in extremity
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Small intestinal obstruction
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Stroke
|
1 Participants
|
Adverse Events
RO4929097
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RO4929097
n=32 participants at risk
Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
General disorders
Death NOS
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Investigations
Lymphocyte count decreased
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Nervous system disorders
Stroke
|
3.1%
1/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
Other adverse events
| Measure |
RO4929097
n=32 participants at risk
Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
21.9%
7/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Cardiac disorders
Sinus bradycardia
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
4/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Constipation
|
21.9%
7/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
6/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Nausea
|
53.1%
17/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
General disorders
Fatigue
|
50.0%
16/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
General disorders
Pain
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Investigations
Platelet count decreased
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Investigations
Weight loss
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
6/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.6%
5/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
4/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
4/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Nervous system disorders
Headache
|
18.8%
6/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.4%
3/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
2/32 • Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years.
Per protocol, Grade 4 myelosuppression does not require expedited reporting via the NCI's Adverse Event Expedited Reporting System (AdEERS). The protocol does not specify that all AEs Gr 3 and higher require expedited reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60