Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer (NCT NCT01620190)
NCT ID: NCT01620190
Last Updated: 2021-07-16
Results Overview
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
Results posted on
2021-07-16
Participant Flow
Seattle Cancer Care Alliance Network Office/University of Washington Phase II open label study enrolled patients at five sites between December 2012 and April 2017.
Twenty-six patients were consented and treated.
Participant milestones
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 Participants
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 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
|
10 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 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
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.Population: All participants who met eligibility criteria and received at least one dose of study intervention and at least one assessment post-baseline.
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
Outcome measures
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 Participants
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Complete Response
|
0 Participants
|
|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Partial Response
|
9 Participants
|
|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Stable Disease
|
6 Participants
|
|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Progressive Disease
|
6 Participants
|
|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Not Evaluable
|
5 Participants
|
SECONDARY outcome
Timeframe: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.Toxicity rates will be described as percentage of patient who experienced a Grade 3 or higher clinically significant toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 Participants
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.
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4 Participants
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SECONDARY outcome
Timeframe: Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 Participants
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Overall Survival
|
36 weeks
Interval 16.8 to 68.0
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SECONDARY outcome
Timeframe: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.Toxicity rates will be described as percentage of patients experiencing Grade 3 or higher toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 Participants
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.
|
8 Participants
|
SECONDARY outcome
Timeframe: Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.Population: 10 patients were not included in the confidence interval as 5 patients passed away before documented radiological Progressive Disease could be assessed and 5 patients initiated new therapy before documented radiological Progressive Disease could be assessed.
Reported as median values with their respective 95% confidence intervals for patients who were assessed. Time to event distribution will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=16 Participants
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Time to Progression.
|
10.2 weeks
Interval 3.4 to 60.9
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Adverse Events
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 participants at risk
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1 • Adverse Events were collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, assessed up to to 64 weeks. All-Cause Mortality was assessed up to 305 weeks.
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
|
Other adverse events
| Measure |
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
n=26 participants at risk
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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General disorders
Fatigue
|
15.4%
4/26 • Number of events 4 • Adverse Events were collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, assessed up to to 64 weeks. All-Cause Mortality was assessed up to 305 weeks.
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
|
|
Nervous system disorders
Peripheral Neuropathy
|
23.1%
6/26 • Number of events 7 • Adverse Events were collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, assessed up to to 64 weeks. All-Cause Mortality was assessed up to 305 weeks.
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
|
|
Investigations
Neutrophil count decreased
|
15.4%
4/26 • Number of events 5 • Adverse Events were collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, assessed up to to 64 weeks. All-Cause Mortality was assessed up to 305 weeks.
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
|
|
Investigations
White blood cell decreased
|
7.7%
2/26 • Number of events 3 • Adverse Events were collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, assessed up to to 64 weeks. All-Cause Mortality was assessed up to 305 weeks.
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place