Trial Outcomes & Findings for Phase II Safety and Tolerability Trial With Nab-Paclitaxel Plus Carboplatin Followed by Nab-Paclitaxel for First Line Treatment of NSCLC Subjects With ECOG PS 2 (NCT NCT02289456)

Last Updated: 2018-12-07

Results Overview

Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months

Results posted on

2018-12-07

Participant Flow

This multicenter study was conducted in the United States (US) and enrolled participants at 7 sites.

Included participants with confirmed Stage IIIB or IV non-small cell lung cancer and measurable disease at study entry per Response Evaluation Criteria in Solid Tumors Version 1.1 with an Eastern Cooperative Oncology Group Performance Status of 2 and no prior anticancer therapy for the treatment of metastatic disease.

Participant milestones

Participant milestones
Measure	Nab-Paclitaxel and Carboplatin During the induction period, participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. In the absence of clinical or radiological disease progression, participants received monotherapy with nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Induction Period STARTED	40
Induction Period Treated Population	40
Induction Period COMPLETED	16
Induction Period NOT COMPLETED	24
Monotherapy Period STARTED	16
Monotherapy Period COMPLETED	0
Monotherapy Period NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-Paclitaxel and Carboplatin During the induction period, participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. In the absence of clinical or radiological disease progression, participants received monotherapy with nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Induction Period Death	2
Induction Period Adverse Event	11
Induction Period Progressive Disease (PD)	4
Induction Period Symptomatic Deterioration	4
Induction Period Withdrawal by Subject	2
Induction Period Miscellaneous	1
Monotherapy Period Death	1
Monotherapy Period Adverse Event	1
Monotherapy Period Progressive Disease (PD)	8
Monotherapy Period Symptomatic Deterioration	1
Monotherapy Period Withdrawal by Subject	2
Monotherapy Period Study Terminated by Sponsor	2
Monotherapy Period Miscellaneous	1

Baseline Characteristics

Treated population included all participants who received at least one dose of any study drug.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.
Age, Continuous	67.4 Years STANDARD_DEVIATION 9.80 • n=5 Participants • Treated population included all participants who received at least one dose of any study drug.
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Race/Ethnicity, Customized Not Hispanic or Latino	37 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Race White	37 Participants n=5 Participants
Race Black	3 Participants n=5 Participants
Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening 0 = Fully Active	0 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening 1 = Restricted in Physical Activity; Ambulatory	0 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening 2 = Ambulatory and Capable of All Self-care	40 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening 3 = Capable of Only Limited Self-care	0 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening 4 = Completely Disabled.	0 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening 5 = Dead	0 Participants n=5 Participants • The Treated population consisted of all participants who received at least 1 dose of Investigational Product.
Histology Squamous	15 Participants n=5 Participants
Histology Non-squamous	25 Participants n=5 Participants
Stage of Disease at Enrollment Stage 0	0 Participants n=5 Participants
Stage of Disease at Enrollment Stage I	0 Participants n=5 Participants
Stage of Disease at Enrollment Stage II	0 Participants n=5 Participants
Stage of Disease at Enrollment Stage IIIb	1 Participants n=5 Participants
Stage of Disease at Enrollment Stage IV	39 Participants n=5 Participants
Number of Participants with Prior Systemic Anticancer Therapies	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months

Population: The Treated population consisted of all participants who received at least 1 dose of Investigational Product.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).	27 Percentage of Participants Interval 14.6 to 43.89	—

SECONDARY outcome

Population: The Treated population consisted of all participants who received at least 1 dose of Investigational Product.

Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate)	60.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months

Population: The treated population consisted of all participants who received at least 1 dose of Investigational Product.

Dose intensity for nab-paclitaxel during the entire study period was (mg/m\^2/week) = \[cumulative dose for nab-paclitaxel in mg/m\^2\] / \[nab-paclitaxel dosing period in weeks\]

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Dose Intensity of Nab-Paclitaxel During the Entire Study	52.173 mg/m^2/week Standard Deviation 10.3066	—

SECONDARY outcome

Timeframe: From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months

Population: The treated population consisted of all participants who received at least 1 dose of investigational Product.

Dose intensity for carboplatin during the entire study period was (mg\*min/mL/week) = \[cumulative dose for carboplatin in mg\*min/mL\] / \[carboplatin dosing period in weeks\].

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Dose Intensity of Carboplatin During the Entire Study	1.170 mg*min/mL/week Standard Deviation 0.4673	—

SECONDARY outcome

Timeframe: From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study

Population: The treated population consisted of all participants who received at least 1 dose of Investigational Product.

A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Percentage of Participants With Dose Reductions During the Entire Study nab-Paclitaxel	32.5 Percentage of Participants	—
Percentage of Participants With Dose Reductions During the Entire Study Carboplatin	27.5 Percentage of Participants	—

SECONDARY outcome

Timeframe: From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

Population: The treated Population consisted of all participants who received at least 1 dose of investigational product.

Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Kaplan Meier Estimate of Progression-Free Survival (PFS)	4.40 months Interval 2.99 to 7.0	—

SECONDARY outcome

Timeframe: Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

Population: The Treated population consisted of all participants who received at least 1 dose of IP

Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate)	75.0 Percentage of Participants Interval 58.8 to 87.31	—

SECONDARY outcome

Timeframe: From Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

Population: The Treated population consisted of all participants who received at least 1 dose of Investigational Product.

Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Kaplan Meier Estimate of Overall Survival (OS)	7.66 months Interval 4.93 to 13.17	—

SECONDARY outcome

Timeframe: Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

Population: Participants who achieved a partial or complete response.

Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines	30.0 Percentage of participants Interval 16.56 to 46.53	—

SECONDARY outcome

Timeframe: From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

Population: Treated Population; participants with a CR or PR

Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=12 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Time to Response	2.00 Months Interval 1.2 to 5.7	—

SECONDARY outcome

Timeframe: From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

Population: Participants in the Treated population with a CR or PR. Participants who were non-responders (i.e., did not achieve at least a PR) were excluded from this analysis.

Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=12 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Kaplan Meier Estimate of Duration of Response	6.83 Months Interval 2.1 to 11.24	—

SECONDARY outcome

Timeframe: From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months

Population: The Treated Population consisted of all participants who received at least 1 dose of IP.

Treatment-emergent adverse events were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel n=16 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Number of Participants With TEAEs During the Induction and Monotherapy Periods Treatment-Related Serious TEAE	13 Participants	0 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods TEAE	40 Participants	14 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Serious TEAE	20 Participants	4 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Grade 1/2 TEAE	39 Participants	14 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Grade 3/4 TEAE	30 Participants	7 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Grade 3 or Higher TEAE	30 Participants	7 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Treatment-Related TEAE	38 Participants	12 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods TEAE With Action to Reduce/Interrupt IP	25 Participants	3 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Treatment-Related to Reduce or Interrupt IP	22 Participants	2 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods TEAE with Action Taken to Withdraw IP	11 Participants	1 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Treatment-Related TEAE Action to Halt IP	8 Participants	1 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods TEAE with Fatal Outcome	1 Participants	0 Participants
Number of Participants With TEAEs During the Induction and Monotherapy Periods Treatment-Related TEAE with Fatal Outcome	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 1 of study drug treatment to end of study drug treatment; up to clinical data cut-off date of 24 February 2017; ; maximum treatment duration was 14.1 months.

Population: The Treated Population consisted of all participants who received at least 1 dose of investigational product.

The percentage of protocol specified dose administered during the induction and monotherapy periods. Percentage of protocol dose = (dose intensity / protocol weekly dose) \* 100%; the protocol weekly dose of nab-paclitaxel is 66.67 mg/m2/week; the protocol weekly dose of carboplatin was 1.67 mg\*min/mL/week.

Outcome measures

Outcome measures
Measure	(Induction Period) Nab-Paclitaxel and Carboplatin n=40 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg\*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression.	Monotherapy Period: Nab-Paclitaxel n=16 Participants Participants received 4 cycles of nab-paclitaxel 100 mg/m\^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Percentage of Protocol Dose nab-Paclitaxel	82.620 Percentage of Protocol Dose Interval 47.11 to 101.2	71.185 Percentage of Protocol Dose Interval 46.32 to 101.61
Percentage of Protocol Dose Carboplatin	80.630 Percentage of Protocol Dose Interval 19.59 to 110.31	NA Percentage of Protocol Dose Carboplatin is not administered in the monotherapy period

Adverse Events

Induction: Nab-Paclitaxel/Carboplatin

Serious events: 20 serious events

Other events: 40 other events

Deaths: 6 deaths

Monotherapy: Nab-Paclitaxel

Serious events: 4 serious events

Other events: 13 other events

Deaths: 2 deaths

Follow-Up Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene sixty days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ninety day and must delete confidential information before submission or defer publication to permit patent applications.
Publication restrictions are in place

Restriction type: OTHER