- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402008
Study of Poziotinib in Japanese Patients With NSCLC
A Phase 1/2 Dose Finding Study of Poziotinib in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Study Overview
Status
Conditions
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 tolerated dose (MTD) or maximum administered dose (MAD) of poziotinib when administered once daily or twice daily. Phase 2 will evaluate the safety and efficacy of the dose determined in Phase 1. Study participation includes a 30 day screening period, up to 24 months of treatment, and long-term follow-up for a maximum of 24 months after discontinuation of study treatment.
Phase 1 will enroll up to 36 patients into a dose finding study with two parallel, randomized dose groups. Each group will undergo a dose-finding scheme using a 3+3 design with the assessment of dose-limiting toxicities (DLTs) at up to three dose levels. Patients will be randomized into once daily (QD) or twice daily (BID) dose groups. The DLT assessment will be conducted in the first cycle of treatment and therefore, poziotinib dose modifications are not permitted during this cycle. Patients will be hospitalized for the first 2 weeks.
Phase 2 will enroll 40 additional NSCLC patients with EGFR (20 patients) or HER2 (20 patients) exon 20 insertion mutations. Efficacy and safety of the dose and dosing regimen determined in Phase 1 will be evaluated. All patients will be treated in 28-day cycles for up to 24 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jaba Kokhreidze, MD
- Phone Number: 949-788-6700
- Email: spi-poz-104@sppirx.com
Study Contact Backup
- Name: Karen Laranjo
- Email: spi-poz-104@sppirx.com
Study Locations
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center East
-
-
Osaka
-
Miyakojima-ku, Osaka, Japan, 534-0021
- Osaka City General Hospital
-
-
Shizuoka
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Sunto District, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- 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, 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 Criteria:
- 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 TKIs that are not considered to be exon 20 insertion-selective are permissible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1: Once Daily Dosing
Dose finding at 8 mg, 12 mg, or 16 mg of poziotinib once daily in 28-day treatment cycles.
|
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
|
Experimental: Phase 1: Twice Daily Dosing
Dose finding at 4 mg, 6 mg, or 8 mg of poziotinib twice daily in 28-day treatment cycles.
|
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
|
Experimental: Phase 2: Once Daily Dosing or Twice Daily Dosing
Once Daily or Twice Daily Dosing as determined in Phase 1 in 28-day treatment cycles. Cohort 1: EGFR exon 20 insertion mutations Cohort 2: HER2 exon 20 insertion mutations |
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Time Frame: 28 Days
|
MTD/MAD will be assessed based on the occurrence of defined dose-limiting toxicities (DLT) and all available safety information during first cycle of treatment.
|
28 Days
|
Phase 2: Objective Response Rate (ORR)
Time Frame: 24 months
|
The proportion of patients who achieve Complete Response (CR) or Partial response (PR) by the best response from the first dose of poziotinib to the end of the study.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 2: Disease Control Rate (DCR)
Time Frame: 24 months
|
The proportion of patients who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of poziotinib to the end of the study.
|
24 months
|
Phase 2: Duration of Response (DoR)
Time Frame: 24 months
|
The number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented.
|
24 months
|
Phase 2: Progression Free Survival (PFS)
Time Frame: 24 months
|
The number of days from the treatment start date to the date of documented disease progression or death.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 2: Exploratory - Overall Survival
Time Frame: 2 years
|
The number of days from the treatment start date to the date of death due to any cause.
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPI-POZ-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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