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Trial record 2 of 39 for:    celgene abi-007 | Open Studies

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 October 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT02027428
First received: January 2, 2014
Last updated: October 3, 2014
Last verified: October 2014
  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, Cross-Over, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel (Abraxane®) 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:
  • Progression free survival (PFS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
    Number of participants to survive without progressing


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

  • Overall Survival [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
    Number of participants who survive

  • Overall response rate [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
    The percentage of patients who achieve an overall response according to Response Evaluation Criteria in Solid Tumors RECIST 1.1 guidelines


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:

A Phase III, randomized, open-label, cross-over, multicenter study of nab-paclitaxel plus best palliative care or best palliative care alone as maintenance treatment after response or stable disease with nab-paclitaxel plus carboplatin as induction in subjects with 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 prior history of other malignancies, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.

    6. Radiographically documented measurable disease at study entry (as defined in Appendix A; lesions in previously irradiated areas [or areas with local therapy] should not be selected as target lesions, unless there has been demonstrated progression in the lesion).

    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 (ie, has had menses at any time during the preceding 24 consecutive months)] must:

    1. Have a negative pregnancy test as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
    2. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 3 months after discontinuation of study therapy.

      Male subjects must:

    3. 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 at least 3 months following study drug discontinuation, even if he has undergone a successful vasectomy.

      * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

      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, Maintenance, or Cross-over 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 ≥ 42 days prior to signing Informed Consent Form).
    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. Myocardial infarction within 6 months prior to signing Informed Consent Form.
    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. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
    12. Any condition that confounds the ability to interpret data from the study.
    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
Contact: Jenny Sheikh, BA 732-652-6318 jsheikh@celgene.com

  Show 87 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
Study First Received: January 2, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Paclitaxel
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
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 November 20, 2014