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Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (ABOUND 70+)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation Identifier:
First received: May 28, 2014
Last updated: August 11, 2016
Last verified: August 2016
Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subject (≥ 70 years old) with advanced NSCLC

Condition Intervention Phase
Non-Small Cell Lung Cancer
Squamous Cell Carcinoma
Carcinoma, Large Cell
Lung Neoplasm
Drug: nab-paclitaxel
Drug: Carboplatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficaty 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+)

Resource links provided by NLM:

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Percentage of participants who will experience either peripheral neuropathy or myelosuppression [ Time Frame: Up to 28 months ] [ Designated as safety issue: Yes ]
    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).

Secondary Outcome Measures:
  • The type, frequency and severity of AEs and SAEs [ Time Frame: Up to 28 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Dose of ABI-007 delivered per unit of time (mg/m2/week)

  • Incidence of dose reduction or delay [ Time Frame: Up to 28 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time between randomization and death

  • Overall response Rate [ Time Frame: Up to 28 months ] [ Designated as safety issue: No ]
    The portion of patients with a tumor reduction of predefined amount for a minimum time period

Estimated Enrollment: 280
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: nab-paclitaxel
Other Name: Abraxane
Drug: 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
Drug: nab-paclitaxel
Other Name: Abraxane
Drug: Carboplatin

Detailed Description:
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.

Ages Eligible for Study:   70 Years and older   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria: -

  • Inclusion Criteria: -

    1. Age ≥ 70 years at the time of signing the Informed Consent Form.
    2. Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
    3. Able to adhere to the study visit schedule and other protocol requirements.
    4. Histologically or cytologically confirmed locally advanced or metastatic Non Small Cell Lung Cancer who are not candidates for curative surgery or radiation therapy.
    5. No other current active malignancy requiring anticancer therapy.
    6. Radiographically documented measurable disease per RECIST v 1.1
    7. No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence. Patients with previously known epidermal growth factor receptor mutation or anaplastic lymphoma kinase gene translocation must have failed or had intolerance to one treatment with epidermal growth factor receptor tyrosine kinase inhibitor or anaplastic lymphoma kinase inhibitor therapy, respectively.
    8. Absolute neutrophil count ≥ 1500 cells/cubic millimetre.
    9. Platelets ≥ 100,000 cells/cubic millimetre.
    10. Hemoglobin ≥ 9 grams/decilitre.
    11. Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upperlimit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
    12. Total bilirubin ≤ 1.5 millilitre/decilitre (unless there is a known history of Gilberts Syndrome).
    13. Creatinine clearance > 40 millilitre/minute calculated using Cockcroft-Gault equation (if renal impairment is suspected 24 hour urine collection for measurement is required).
    14. Eastern Cooperative Oncology Group performance status 0 or 1.
    15. Females who (1) have undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been naturally postmenopausal for at least 24 consecutive months (ie, has not had menses at any time during the preceding 24 consecutive months).
    16. Male subjects must: Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.

      Exclusion Criteria:

  • 1. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.

    2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable. 4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).

    5. Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, 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.

    6. Venous thromboembolism within 1 month prior to signing Informed consent form.

    7. Current congestive heart failure (New York Heart Association Class II-IV). 8. History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder. 9. Subject has a known infection with hepatitis B or C, or history of human immunodeficiency virus infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.

    10. Subject has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.

    11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.

    12. Treatment with any investigational product within 28 days prior to signing the Informed consent form.

    13. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14. Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices. 15. Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.

    16. Subject has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b). All treatment of which should have been completed 6 months prior to signing Informed consent form.

    17. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.

    18. Any medical condition that confounds the ability to interpret data from the study.

    19. Females who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02151149

Contact: Amy Kellerman 1-913-266-0320

  Show 56 Study Locations
Sponsors and Collaborators
Celgene Corporation
Study Director: Teng Jin Ong Celgene
  More Information

Responsible Party: Celgene Corporation Identifier: NCT02151149     History of Changes
Other Study ID Numbers: ABI-007-NSCL-005 
Study First Received: May 28, 2014
Last Updated: August 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
NSCLC advanced non-small cell lung cancer squamous adenocarcinoma large cell carcinoma lung cancer elderly first line treatment abraxane carbo nab-paclitaxel

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Carcinoma, Large Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016