Trial Outcomes & Findings for Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma (NCT NCT02945800)
NCT ID: NCT02945800
Last Updated: 2026-01-26
Results Overview
Treatment response will be assessed with the most relevant imaging studies (e.g., CT or MRI) after every two cycles. Standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to assess responses. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
13 months
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=59 Participants
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
Age, Continuous
|
18.7 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 13 monthsTreatment response will be assessed with the most relevant imaging studies (e.g., CT or MRI) after every two cycles. Standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to assess responses. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination Therapy
n=59 Participants
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
Response Rate
|
15.3 percentage of participants
Interval 7.2 to 27.0
|
PRIMARY outcome
Timeframe: 13 monthsProgression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm).
Outcome measures
| Measure |
Combination Therapy
n=59 Participants
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
Progression Free Survival (PFS)
|
1.91 Months
Interval 1.64 to 4.21
|
SECONDARY outcome
Timeframe: 13 monthsPopulation: A total of 54 out of 59 patients experienced at least one event related to the study treatment.
Adverse Events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0, deemed to be caused by study treatment.
Outcome measures
| Measure |
Combination Therapy
n=59 Participants
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
Occurrence of Study Treatment Related Adverse Events
|
54 participants
|
Adverse Events
Combination Therapy
Serious events: 35 serious events
Other events: 58 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Combination Therapy
n=59 participants at risk
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.9%
7/59 • Number of events 7 • 13 Months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.5%
5/59 • Number of events 6 • 13 Months
|
|
Cardiac disorders
Sinus tachycardia
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Nausea
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
General disorders
Fatigue
|
1.7%
1/59 • Number of events 2 • 13 Months
|
|
General disorders
Fever
|
25.4%
15/59 • Number of events 18 • 13 Months
|
|
General disorders
Localized edema
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
General disorders
Non-cardiac chest pain
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Infections and infestations
Esophageal infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Infections and infestations
Lung infection
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Infections and infestations
Skin infection
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Investigations
Neutrophil count decreased
|
5.1%
3/59 • Number of events 4 • 13 Months
|
|
Investigations
Platelet count decreased
|
8.5%
5/59 • Number of events 6 • 13 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.5%
5/59 • Number of events 6 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Vascular disorders
Hypotension
|
8.5%
5/59 • Number of events 5 • 13 Months
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
General disorders
Edema limbs
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
General disorders
Pain
|
13.6%
8/59 • Number of events 9 • 13 Months
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/59 • Number of events 2 • 13 Months
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Investigations
Creatinine increased
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Seizure
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Syncope
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Tooth infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Wound infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Investigations
White blood cell decreased
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/59 • Number of events 2 • 13 Months
|
Other adverse events
| Measure |
Combination Therapy
n=59 participants at risk
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
nab-Paclitaxel: nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: Gemcitabine: 1000 mg/m\^2 intravenously (IV)
|
|---|---|
|
General disorders
Non-cardiac chest pain
|
6.8%
4/59 • Number of events 5 • 13 Months
|
|
General disorders
Edema limbs
|
5.1%
3/59 • Number of events 5 • 13 Months
|
|
General disorders
Localized edema
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
10.2%
6/59 • Number of events 8 • 13 Months
|
|
Gastrointestinal disorders
Nausea
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Gastrointestinal disorders
Mucositis oral
|
3.4%
2/59 • Number of events 3 • 13 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Oral pain
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.3%
9/59 • Number of events 10 • 13 Months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.5%
5/59 • Number of events 6 • 13 Months
|
|
Nervous system disorders
Headache
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Nervous system disorders
Syncope
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Seizure
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.3%
9/59 • Number of events 10 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.4%
2/59 • Number of events 3 • 13 Months
|
|
Infections and infestations
Lung infection
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Infections and infestations
Skin infection
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Infections and infestations
Tooth Infection
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Infections and infestations
Esophageal infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Infections and infestations
Wound infection
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.2%
6/59 • Number of events 7 • 13 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
4/59 • Number of events 4 • 13 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
4/59 • Number of events 6 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Sinus tachycardia
|
6.8%
4/59 • Number of events 6 • 13 Months
|
|
Cardiac disorders
Pericardial effusion
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Vascular disorders
Hypertension
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Vascular disorders
Hypotension
|
5.1%
3/59 • Number of events 3 • 13 Months
|
|
Vascular disorders
Thromboembolic event
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Hematuria
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.5%
5/59 • Number of events 6 • 13 Months
|
|
General disorders
Fever
|
23.7%
14/59 • Number of events 16 • 13 Months
|
|
General disorders
Fatigue
|
10.2%
6/59 • Number of events 7 • 13 Months
|
|
General disorders
Pain
|
8.5%
5/59 • Number of events 6 • 13 Months
|
|
Investigations
Neutrophil count decreased
|
61.0%
36/59 • Number of events 75 • 13 Months
|
|
Investigations
Platelet count decreased
|
57.6%
34/59 • Number of events 82 • 13 Months
|
|
Investigations
White blood cell decreased
|
55.9%
33/59 • Number of events 60 • 13 Months
|
|
Investigations
Lymphocyte count decreased
|
47.5%
28/59 • Number of events 48 • 13 Months
|
|
Investigations
Alanine aminotransferase increased
|
16.9%
10/59 • Number of events 14 • 13 Months
|
|
Investigations
Aspartate aminotransferase increased
|
8.5%
5/59 • Number of events 5 • 13 Months
|
|
Investigations
Alkaline phosphatase increased
|
3.4%
2/59 • Number of events 2 • 13 Months
|
|
Investigations
Blood bilirubin increased
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Investigations
Creatinine increased
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Investigations
Investigations - Other, specify
|
1.7%
1/59 • Number of events 1 • 13 Months
|
|
Blood and lymphatic system disorders
Anemia
|
61.0%
36/59 • Number of events 68 • 13 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place