Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (ABOUND 70+)
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|ClinicalTrials.gov Identifier: NCT02151149|
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer Carcinoma Squamous Cell Carcinoma Adenocarcinoma Carcinoma, Large Cell Lung Neoplasm||Drug: nab-paclitaxel Drug: Carboplatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Nab-paclitaxel (Abraxane) in Combination With Carboplatin as First Line Treatment in Elderly Subjects With Advance Non-Small Cell Lung Cancer (NSCLC): A Phase IV, Randomized, Open-Label, Multicenter Study (Abound.70+)|
|Actual Study Start Date :||June 9, 2014|
|Actual Primary Completion Date :||July 14, 2017|
|Actual Study Completion Date :||July 14, 2017|
Arm A: nab-Paclitaxel and Carboplatin (Every 21 days)
nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of every 21-day treatment cycle
Other Name: AbraxaneDrug: Carboplatin
Arm B: nab-Paclitaxel and Carboplatin (Every 28 days)
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment followed by one-week break and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of each 21-day treatment followed by one-week break
Other Name: AbraxaneDrug: Carboplatin
- Percentage of participants who will experience either peripheral neuropathy or myelosuppression [ Time Frame: Up to 28 months ]The peripheral neuropathy events will be identified from the clinical AE dataset using MedDRA. Myelosuppression will be assessed as an adverse event based on laboratory values. All AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0).
- The type, frequency and severity of AEs and SAEs [ Time Frame: Up to 28 months ]An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any clinically significant change in the frequency or intensity of a pre-existing condition should be considered an AE. TEAEs will be analyzed which are defined as any AE or SAE occurring or worsening on or after the first dose of the study drug through 28 days after the last dose of study drug. Any serious AE with an onset date more than 28 days after the last dose of study drug that is assessed as related to study drug will be considered a TEAE. AEs will be coded according to the Medical Dictionary for Regulatory Activities. The severity of AEs will be graded based on NCI Common Terminology Criteria for Adverse Events, Version 4.0.
- Discontinuation Rate [ Time Frame: Up to 28 months ]Percentage of participants who will discontinue from study due to progressive disease, toxicity, withdrawal from study, protocol violation or other specified reasons
- Dose Intensity [ Time Frame: Up to 28 months ]Dose of ABI-007 delivered per unit of time (mg/m2/week)
- Incidence of dose reduction or delay [ Time Frame: Up to 28 months ]The number of participants with dose reductions and dose delays that occur during the treatment period. Dose reductions and delays are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events/toxicities.
- Progression-free Survival [ Time Frame: Up to 28 months ]Time from the date of randomization to the date of disease progression or death (any cause) on or prior to the data cutoff date for analyses, whichever occurred first, based on the assessment of the data from CT scans using RECIST 1.1 guidelines.
- Overall Survival [ Time Frame: Up to 28 months ]Time between randomization and death
- Overall response Rate [ Time Frame: Up to 28 months ]The portion of patients with a tumor reduction of predefined amount for a minimum time period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151149
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|Study Director:||Teng Jin Ong||Celgene|