Status:
TERMINATED
Study of Poziotinib in Japanese Patients With NSCLC
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
NSCLC
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).
Detailed Description
This is a Phase 1/2, open-label, multicenter study in Japanese patients with locally advanced or metastatic NSCLC. This study will be conducted in two parts. Phase 1 is designed to observe the maximum...
Eligibility Criteria
Inclusion
- Key
- Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
- Previously treated patient with histologically or cytologically confirmed (archival tissue accepted) locally advanced or metastatic non-small cell lung cancer (NSCLC) and is not a candidate for definitive therapy
- Phase 1: No test for mutational status is required
- Phase 2: Documented EGFR or HER2 exon 20 insertion mutations (including duplication mutations) in NSCLC patients
- Prior treatment status:
- Phase 1: Patient with refractory NSCLC to available standard therapies
- Phase 2: Progression after at least one systemic therapy for locally advanced or metastatic disease
- Patient has measurable NSCLC disease, as per the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Metastatic lesions in bone, central nervous system (CNS), or in brain cannot be used for target lesions.
- Patient has recovered from prior systemic therapy for metastatic disease to Grade ≤1 for non-hematologic toxicities (except for Grade ≤2 peripheral neuropathy) and has adequate hematologic, hepatic, and renal function at Baseline
- Key
Exclusion
- Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks prior to Cycle 1, Day 1; local radiation therapy for bone pain may be allowed
- Patient has used strong inhibitors/inducers of CYP3A4 and CYP2D6 within 1 month prior to Cycle 1, Day 1
- Patient has had another primary malignancy within 3 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ
- Patient is pregnant or breastfeeding
- Phase 2 : Patient has had previous treatment with poziotinib. The currently approved tyrosine kinase inhibitors (TKIs) that are not considered to be exon 20 insertion-selective are permissible
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04402008
Start Date
June 23 2020
End Date
February 15 2023
Last Update
June 25 2024
Active Locations (3)
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1
National Cancer Center East
Kashiwa, Chiba, Japan, 277-8577
2
Osaka City General Hospital
Miyakojima-ku, Osaka, Japan, 534-0021
3
Shizuoka Cancer Center
Sunto District, Shizuoka, Japan, 411-8777