Summary

for people ages 18 years and up (full criteria)
at UCSD
study started
estimated completion:

Description

Summary

Maintenance treatment of advanced stage squamous cell NSCLC

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)

Details

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.

Keywords

Squamous Cell Carcinoma, Non-Small-Cell Lung Nab-paclitaxel Albumin bound paclitaxel Taxanes Maintenance trials Celgene Abraxane ABI-007 NSCLC Non-Small Cell Lung Cancer Cancer of the Lung Carcinoma, Squamous Cell Lung Neoplasms Abound.sqm Carcinoma, Non-Small-Cell Lung Paclitaxel Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents Abraxane (Induction) Carboplatin (Induction) Abraxane (Maintenance) Best Supportive Care (Maintenance)

Eligibility

You can join if…

Open to people ages 18 years and up

    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.
  • 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.
  • No other current active malignancy requiring anticancer therapy.
  • Radiographically documented measurable disease at study entry (as defined by the RECIST v1.1 criteria).
  • 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.
  • 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.
  • . Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
  • . 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:
  • agree to take a pregnancy test prior to starting study medication and throughout the study participation.
  • 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:

  1. 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.
  2. . Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.

You CAN'T join if...

  • 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):
  • 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).
  • Only evidence of disease is non measurable at study entry.
  • Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
  • Venous thromboembolism within 6 months prior to signing Informed Consent Form.
  • Current congestive heart failure (New York Heart Association class II-IV).
  • 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.
  • 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.
  • . Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
  • . 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.
  • . 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.
  • . Pregnant and nursing females.

Locations

  • University of California San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Cancer Care Associates of Fresno Medical Group Inc
    Fresno California 93720 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02027428
Phase
Phase 3
Study Type
Interventional
Last Updated