A Phase II, Single Arm, Open-Label, Multicenter, Safety and Tolerability Trial With Nab-Paclitaxel (ABRAXANE®) Plus Carboplatin Followed by Nab-Paclitaxel Monotherapy as First-Line Treatment for Subjects With Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (NSCLC) and an Eastern Cooperative Oncology Group Performance Status of 2 (ABOUND.PS2)

Celgene8 sites in 1 country40 target enrollmentApril 28, 2015

ConditionsCarcinoma, Non-Small-Cell Lung

Interventionsnab-Paclitaxel Carboplatin

Drugsnab-Paclitaxel Carboplatin

Overview

Phase: Phase 2
Intervention: nab-Paclitaxel
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Celgene
Enrollment: 40
Locations: 8
Primary Endpoint: Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4 cycles.

Registry

clinicaltrials.gov

Start Date

April 28, 2015

End Date

February 22, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General and Demographics
•Age ≥ 18 years of age at the time of signing the Informed Consent Form.
•Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
•Able to adhere to the study visit schedule and other protocol requirements. Disease Specific
•Histologically or cytologically confirmed Stage IIIB or IV Non-Small Cell Lung Cancer.
•Radiographically documented measurable disease at study entry per response evaluation criteria in solid tumours ( RECIST) v1.
•No prior anti-cancer therapy for the treatment of metastatic disease at the time of signing the ICF. Adjuvant treatment is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence.
•Absolute neutrophil count (ANC) ≥ 1500 cells/mm
•Platelets ≥ 100,000 cells/mm
•Hemoglobin (Hgb) ≥ 9 g/dL.

Exclusion Criteria

•The presence of any of the following will exclude a subject from enrollment:
•Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for at least 21days prior to signing ICF). MRI of the brain (or CT scan w/contrast) is preferred for diagnosis.
•History of leptomeningeal disease.
•Only evidence of disease is non-measurable.
•Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Criteria for Adverse Events (CTCAE) v4.0).
•Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product (IP), and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
•Venous thromboembolism within 1 month prior to signing ICF.
•Current congestive heart failure (New York Heart Association Class II-IV).
•History of the following within 6 months prior to first administration of investigational product: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
•Subject has a known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.

Arms & Interventions

nab-Paclitaxel

nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle • Carboplatin AUC = 5 mg\*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion.

Intervention: nab-Paclitaxel

nab-Paclitaxel

Intervention: Carboplatin

Outcomes

Primary Outcomes

Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).

Time Frame: 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

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.

Secondary Outcomes

Dose Intensity of Nab-Paclitaxel During the Entire Study(From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months)
Dose Intensity of Carboplatin During the Entire Study(From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months)
Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate)(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)
Time to Response(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)
Kaplan Meier Estimate of Duration of Response(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)
Kaplan Meier Estimate of Overall Survival (OS)(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)
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines(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)
Number of Participants With TEAEs During the Induction and Monotherapy Periods(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)
Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate)(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)
Percentage of Participants With Dose Reductions During the Entire Study(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)
Kaplan Meier Estimate of Progression-Free Survival (PFS)(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)