Trial Outcomes & Findings for Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer (NCT NCT02769832)
NCT ID: NCT02769832
Last Updated: 2025-07-29
Results Overview
Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scan: Complete response (CR) is the disappearance of all target lesions. Partial Response (PR), is at least a ≥ 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum of the longest diameter (LD). Progression of disease (PD) is at least a ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and as defined by RECIST v1.1 guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Results posted on
2025-07-29
Participant Flow
Treatment began following screening and within 14 days after screening, if patient is eligible and completed all required testing including medical history, physical exam including performance status, blood samples, pregnancy test, and tumor assessment done by computerized tomography (CT) scan, Chest X-Ray (CXR), or Magnetic Resonance Imaging (MRI).
Participant milestones
| Measure |
Nab-Paclitaxel With Gemcitabine
Nab-paclitaxel: 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine: 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Nab-Paclitaxel With Gemcitabine
Nab-paclitaxel: 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine: 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Overall Study
Death
|
30
|
Baseline Characteristics
Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer
Baseline characteristics by cohort
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 Participants
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scan: Complete response (CR) is the disappearance of all target lesions. Partial Response (PR), is at least a ≥ 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum of the longest diameter (LD). Progression of disease (PD) is at least a ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and as defined by RECIST v1.1 guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 Participants
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Overall Response Rate
Complete Response
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
9 Participants
|
|
Overall Response Rate
Stable Disease
|
16 Participants
|
|
Overall Response Rate
Progressive Disease
|
7 Participants
|
SECONDARY outcome
Timeframe: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)Progression-free survival is defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients are censored at the date of last radiographic assessment for progression.
Outcome measures
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 Participants
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Progression-Free Survival
|
2.9 months
Interval 2.4 to 3.6
|
SECONDARY outcome
Timeframe: Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)Time to progression is defined as the time from treatment initiation to the date of first documentation of disease progression per RECIST v1.1. Otherwise, patients are censored at last radiographic assessment for progression.
Outcome measures
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 Participants
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Time to Progression
|
2.9 months
Interval 2.4 to 3.8
|
SECONDARY outcome
Timeframe: Patients will be evaluated every 3 months until death or study completion (up to 3 years)Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.
Outcome measures
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 Participants
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Overall Survival
|
9.3 months
Interval 5.2 to 12.4
|
Adverse Events
Nab-Paclitaxel With Gemcitabine
Serious events: 14 serious events
Other events: 32 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 participants at risk
Nab-paclitaxel: 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine: 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Cardiac disorders
Myocardial infarction
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Fever
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Lung infection
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Skin infection
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Upper respiratory infection
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Platelet count decreased
|
9.4%
3/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Stroke
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitits
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Superior vena cava syndrome
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Thromboembolic event
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
Other adverse events
| Measure |
Nab-Paclitaxel With Gemcitabine
n=32 participants at risk
Nab-paclitaxel: 100 mg/m2, day 1 and day 8 of a 21-day cycle; Gemcitabine: 1000 mg/m2, day 1 and day 8 of a 21-day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
59.4%
19/32 • Number of events 59 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Cardiac disorders
Chest pain - cardiac
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Cardiac disorders
Heart failure
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Eye disorders
Dry eye
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
4/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
8/32 • Number of events 9 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
34.4%
11/32 • Number of events 12 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
15.6%
5/32 • Number of events 6 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
12.5%
4/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.4%
3/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
12/32 • Number of events 23 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
8/32 • Number of events 18 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Chills
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Edema limbs
|
31.2%
10/32 • Number of events 13 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Fatigue
|
62.5%
20/32 • Number of events 42 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Fever
|
18.8%
6/32 • Number of events 13 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Gait disturbance
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Infusion related reaction
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Infusion site extravasation
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Malaise
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Bronchial infection
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Lung infection
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Otitis externa
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Skin infection
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Upper respiratory infection
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Number of events 5 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
3/32 • Number of events 8 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Alkaline phosphatase increased
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
4/32 • Number of events 6 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Blood bilirubin increased
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Creatinine increased
|
9.4%
3/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
GGT increased
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Neutrophil count decreased
|
68.8%
22/32 • Number of events 46 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Platelet count decreased
|
59.4%
19/32 • Number of events 57 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Weight gain
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Investigations
Weight loss
|
21.9%
7/32 • Number of events 14 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
8/32 • Number of events 10 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
4/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.4%
3/32 • Number of events 6 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
8/32 • Number of events 15 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.4%
3/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
6/32 • Number of events 13 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
4/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Cognitive disturbance
|
3.1%
1/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Dysarthria
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Lethargy
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
4/32 • Number of events 5 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Nervous system disorders
Stroke
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Psychiatric disorders
Confusion
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
6/32 • Number of events 8 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
3/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.6%
5/32 • Number of events 5 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
4/32 • Number of events 4 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.4%
3/32 • Number of events 3 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.1%
1/32 • Number of events 1 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Hypotension
|
12.5%
4/32 • Number of events 9 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Phlebitis
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Superior vena cava syndrome
|
3.1%
1/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
2/32 • Number of events 2 • All adverse events were recorded from the time the subject signs informed consent until 28 days after the last dose of Abraxane and Gemcitabine, up to 4 years.
|
Additional Information
Muhammad Furqan, MD
University of Iowa, Holden Comprehensive Cancer Center
Phone: 319-356-1527
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place