Trial Outcomes & Findings for Treatment With Nab-paclitaxel in Cutaneous SCC (NCT NCT02076243)
NCT ID: NCT02076243
Last Updated: 2017-10-25
Results Overview
the percentage of subjects who develop Complete Response (CR) or Partial Response (PR)
TERMINATED
PHASE2
2 participants
at week 8 post treatment
2017-10-25
Participant Flow
Participant milestones
| Measure |
Nab-paclitaxel
weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.
nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment With Nab-paclitaxel in Cutaneous SCC
Baseline characteristics by cohort
| Measure |
Nab-paclitaxel
n=2 Participants
weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.
nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at week 8 post treatmentPopulation: study terminated, results not collected
the percentage of subjects who develop Complete Response (CR) or Partial Response (PR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: average 5 yearsPopulation: study terminated, results not collected
every eight weeks will reassess efficacy by imaging and can continue treatment if no progression and expect will be up to an average 5 years
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at baselinePopulation: study terminated, results not collected
prevalence of SPARC expression in advanced squamous cell cancer of the skin. The tumor specimen used to determine SPARC expression wll be obtained from a biopsy previously performed as standard of care (such as to establish the diagnosis).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at week 8 post treatmentPopulation: study terminated, results not collected
correlation of response to first line treatment with Nab-Paclitaxel with SPARC expression, with target lesions measured at the longest diameter of each non-lymph node lesion and the short axis for target lymph nodes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 5 yearsnumber of participants with adverse events as a measure of safety and tolerability
Outcome measures
| Measure |
Nab-paclitaxel
n=2 Participants
weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.
nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).
|
|---|---|
|
Safety and Tolerability
|
2 Participants
|
Adverse Events
Nab-paclitaxel
Serious adverse events
| Measure |
Nab-paclitaxel
n=2 participants at risk
weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.
nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).
|
|---|---|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Fall
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Weakness
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
Altered Mental Status
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
Nab-paclitaxel
n=2 participants at risk
weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.
nab-paclitaxel: nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).
|
|---|---|
|
Blood and lymphatic system disorders
White blood cell decreased
|
50.0%
1/2 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbumenia
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain Right shoulder
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Fall
|
50.0%
1/2 • Number of events 1
|
Additional Information
Dr. Philip Friedlander
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place