WithdrawnPhase 2NCT02405910

Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.

Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC).

Checked against the public recordLast updated Nov 6, 2017 · Source: ClinicalTrials.gov

StatusWithdrawn
PhasePhase 2
U.S. locations1
SponsorWest Virginia University
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
West Virginia University
Interventions being studied
Drug: Nab-paclitaxel; Drug: Gemcitabine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Patients with histologically proven newly diagnosed stage IV or stage IIIB non-squamous Non-small Cell Lung Cancer (NSCLC) - Recurrent advanced NSCLC will be allowed if they have never received chemotherapy for metastatic disease. - Prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Washout period of 4 weeks for chemo/radiation/experimental agents * Resolution of all toxicities to \< grade 2 prior to starting treatment (excluding alopecia) * Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE) * Adequate hepatic, renal, and bone marrow functions * Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment * Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential Exclusion Criteria: * Patient with New York Heart Association class III or IV heart failure * Women of child bearing potential (WOCBP) are not currently pregnant or breast-feeding * Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma * Previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded * Grade ≥2 peripheral neuropathy at baseline assessment from any cause * Symptomatic brain metastases will be excluded. Treated Brain metastases will be allowed that are neurologically stable. * Patients with adenocarcinoma with activating EGFR mutation (exon 19 deletions / insertions, exon 21 point mutations) or EML4-ALK translocation are excluded unless they are ineligible for epidermal growth factor receptor (EGFR) or ALK targeting agents. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • West Virginia University Hospitals - Mary Babb Randolph Cancer CenterMorgantown, West Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 6, 2017. Always confirm current availability with the study team.

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