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Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer (aboundsqm)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT02027428
First received: January 2, 2014
Last updated: June 19, 2015
Last verified: June 2015
  Purpose

Maintenance treatment of advanced stage squamous cell NSCLC


Condition Intervention Phase
Squamous Cell Carcinoma, Non-Small-Cell Lung
Drug: Abraxane (Induction)
Drug: Carboplatin (Induction)
Drug: Abraxane (Maintenance)
Other: Best Supportive Care (Maintenance)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Progress free survival from randomization to the maintainence part of the study [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
    To evaluate Progress Free Survival (PFS) with nab-Paclitaxel as maintenance treatment after response or stable disease (SD) with nab-Paclitaxel plus carboplatin with subjects with squamous cell NSCLC.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Efficacy - overall survival from randomization into the maintainence part of the study. [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time between randomization and Description: Overall survival is defined as the time between randomization and part of the study

  • Efficacy - overall response rate during the induction and maintainence part of the study. [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
    The percentage for randomized subjects having an overall confirmed CR or PR using the RECIST 1.1 guidelines over the entire study.


Estimated Enrollment: 260
Study Start Date: December 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abraxane + Best Supportive Care (BSC)
Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes Abraxane plus best supportive care.
Drug: Abraxane (Induction)
100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care
Other Name: nab-paclitaxel
Drug: Carboplatin (Induction)
6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion
Drug: Abraxane (Maintenance)
100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care
Other: Best Supportive Care (Maintenance)
The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents
Best Supportive Care (BSC)
Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes best supportive care only.
Drug: Abraxane (Induction)
100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care
Other Name: nab-paclitaxel
Drug: Carboplatin (Induction)
6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care
Other: Best Supportive Care (Maintenance)
The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents

Detailed Description:

Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or SD with nab-paclitaxel plus carboplatin as induction in subjects with stage IIB/IV squamous cell NSCLC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age ≥ 18 years of age at the time of signing the Informed Consent Form. 2. Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.

    3. Able to adhere to the study visit schedule and other protocol requirements Disease Specific 4. Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.

    5. No other current active malignancy requiring anticancer therapy.

    6. Radiographically documented measurable disease at study entry (as defined by the RECIST v1.1 criteria).

    7. No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.

    8. Absolute neutrophil count ≥ 1500 cells/mm3. 9. Platelets ≥ 100,000 cells/mm3. 10. Hemoglobin ≥ 9 g/dL. 11. Aspartate transaminase/serum glutamic oxaloacetic transaminase, alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.

    12. Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.

    13. Creatinine ≤ 1.5 mg/dL. 14. Expected survival of > 12 weeks for the Induction part of the study. 15. Eastern Cooperative Oncology Group performance status 0 or 1. 16. For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction Pregnancy 17. Females of childbearing potential [defined as a sexually mature woman 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 (i.e., has had menses at any time during the preceding 24 consecutive months)] must:

    1. agree to take a pregnancy test prior to starting study medication and throughout the study participation.
    2. commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations.

      Male subjects must:

    3. agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy.

      18. Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.

      Exclusion Criteria:

  • The presence of any of the following will exclude a subject from enrollment into the Induction and Maintenance parts of the study (except if specified at study entry only):

    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 first dose of study drug).
    2. Only evidence of disease is non measurable at study entry.
    3. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
    4. Venous thromboembolism within 6 months prior to signing Informed Consent Form.
    5. Current congestive heart failure (New York Heart Association class II-IV).
    6. 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 (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.7. Treatment with any investigational product within 28 days prior to signing Informed Consent Form.

    8. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 9. Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.

    10. Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.

    11. 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 treatments that should have been completed 6 months prior to signing ICF.

    12. Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting 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.

    13. Pregnant and nursing females.

  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 ClinicalTrials.gov identifier: NCT02027428

Contacts
Contact: Duong Ngyuen, Pharm. D. (415) 839-7097 dnguyen@celgene.com

  Show 89 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Teng Jin Ong, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02027428     History of Changes
Other Study ID Numbers: ABI-007-NSCL-003, 2014-003804-66
Study First Received: January 2, 2014
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Non-Small Cell Lung Cancer
Cancer of the Lung
Lung Neoplasms
Nab-paclitaxel
Albumin bound paclitaxel
Taxanes
Maintenance trials
Celgene
Abraxane
ABI-007
NSCLC
Carcinoma, Squamous Cell
Abound.sqm

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Carcinoma, Bronchogenic
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on August 30, 2015