Trials / Terminated
TerminatedNCT01819428
NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma
A Prospective, Open-label, Single Arm, Multi-center, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) as the First-line Treatment Medication in Patients With Harboring EGFR Mutations
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- National OncoVenture · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.
Detailed description
EGFR TKIs are known as more effective and less toxic medications against EGFR mutated tumors. However, newly acquired resistance to these inhibitors is the inevitable obstacle in continuous treatment with them. To overcome this problem, many new class of TKIs including NOV120101 (Poziotinib) are developing these days. To evaluate the efficacy of NOV120101 (Poziotinib) as a first-line monotherapeutic medication, chemotherapy-naïve patients will participate in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily until disease progression or unacceptable toxicity development. Objective response rate (ORR) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 months, DCR, PFS, and OS will also be analyzed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NOV120101 (Poziotinib) | NOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity development |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2013-03-27
- Last updated
- 2016-03-01
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01819428. Inclusion in this directory is not an endorsement.