Trial Outcomes & Findings for Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer (NCT NCT02152137)
NCT ID: NCT02152137
Last Updated: 2025-01-27
Results Overview
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2025-01-27
Participant Flow
Patients assigned to arm A will receive both paclitaxel and efatutazone; patients assigned to arm B will receive paclitaxel alone. However, please note that with update #2, arm B is closed and all patients should receive paclitaxel and efatutazone.
Participant milestones
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
Originally Assigned to Arm A
|
16
|
|
Overall Study
Originally Assigned to Arm B
|
3
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Originally assigned to Arm B
|
3
|
Baseline Characteristics
Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 Participants
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
ECOG Performance Status
0
|
4 Participants
n=99 Participants
|
|
ECOG Performance Status
1
|
9 Participants
n=99 Participants
|
|
ECOG Performance Status
2
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Patients who received efatutazone and paclitaxel combination were included in this analysis.
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Outcome measures
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 Participants
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria
|
13 percentage of patients
Interval 2.0 to 40.0
|
SECONDARY outcome
Timeframe: Time from study entry to death from any cause, assessed up to 5 yearsPopulation: Patients who received efatutazone and paclitaxel combination were included in this analysis.
Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 Participants
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
6.6 months
Interval 4.2 to 27.3
|
SECONDARY outcome
Timeframe: The time from the first documented date of confirmed response (CR or PR) to date at which progression is first documented, assessed up to 5 yearsPopulation: Only patients who achieved a confirmed response are included in this analysis.
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
Outcome measures
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=2 Participants
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Confirmed Response
Patient #1
|
12.2 months
|
|
Duration of Confirmed Response
Patient #2
|
3.2 months
|
SECONDARY outcome
Timeframe: The time from study entry to the first of either disease progression or death from any cause, assessed up to 5 yearsPopulation: Patients who received efatutazone and paclitaxel combination were included in this analysis.
Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 Participants
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
PFS Determined Based on RECIST 1.1 Criteria
|
2.5 months
Interval 1.2 to 6.3
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients who received efatutazone and paclitaxel combination were included in this analysis.
The number of patients who experienced at least one grade 3 or higher adverse event is reported below.
Outcome measures
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 Participants
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
|
13 Participants
|
Adverse Events
Efatutazone Dihydrochloride, Paclitaxel
Serious events: 8 serious events
Other events: 14 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 participants at risk
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
3/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Death NOS
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Edema limbs
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Neck edema
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Immune system disorders
Anaphylaxis
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
3/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Vascular disorders
Superior vena cava syndrome
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
Other adverse events
| Measure |
Efatutazone Dihydrochloride, Paclitaxel
n=15 participants at risk
Patients receive 175 mg/m\^2 paclitaxel IV over 3 hours on day 1 and 0.5 mg efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
12/15 • Number of events 45 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Cardiac disorders
Pericardial effusion
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Bloating
|
6.7%
1/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 5 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
3/15 • Number of events 5 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • Number of events 8 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.7%
1/15 • Number of events 14 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 21 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Edema face
|
13.3%
2/15 • Number of events 5 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Edema limbs
|
66.7%
10/15 • Number of events 51 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Fatigue
|
60.0%
9/15 • Number of events 29 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Neck edema
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 4 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Blood bilirubin increased
|
13.3%
2/15 • Number of events 6 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Cholesterol high
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Creatinine increased
|
20.0%
3/15 • Number of events 5 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Investigations - Other, specify
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
5/15 • Number of events 7 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Neutrophil count decreased
|
40.0%
6/15 • Number of events 17 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Platelet count decreased
|
20.0%
3/15 • Number of events 6 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
Weight gain
|
60.0%
9/15 • Number of events 36 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Investigations
White blood cell decreased
|
40.0%
6/15 • Number of events 21 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
3/15 • Number of events 6 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
26.7%
4/15 • Number of events 9 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
3/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 4 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
1/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
6.7%
1/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Nervous system disorders
Paresthesia
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
10/15 • Number of events 50 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
4/15 • Number of events 5 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
40.0%
6/15 • Number of events 14 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15 • Number of events 1 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.7%
4/15 • Number of events 26 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 7 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
1/15 • Number of events 8 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
6.7%
1/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
13.3%
2/15 • Number of events 3 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Number of events 2 • Up to 5 years
Evaluable patients who received efatutazone and paclitaxel combination and had adverse events assessed are summarized below.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place