Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
The Maximum Tolerated Dose and to Evaluate Safety and Efficacy of Belinostat (PXD-101) in Combination With Paclitaxel Plus Carboplatin in Chemotherapy-Naive Patients With Stage IV Non-Small-Cell Lung Cancer (NSCLC)
Verified date | January 2020 |
Source | Acrotech Biopharma LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung Cancer (NSCLC).
Status | Completed |
Enrollment | 23 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - A histologically or cytologically confirmed diagnosis of Stage IV (M1a or M1b) NSCLC. Patients with mixed non-small cell histologies are eligible - No prior chemotherapy for the treatment of advanced NSCLC - Prior adjuvant therapy for early stage lung cancer is allowed if completed = 12 months prior to enrollment - Age >= 18 years - Adequate organ function - Any treatment with investigational agent must have completed = 4 weeks prior to enrollment - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Negative pregnancy test for women of childbearing potential. - Patients with brain metastases allowed if: - Directed local therapy was completed 2 weeks prior to enrollment; - There is no evidence of disease progression and; - Steroids are not required Exclusion Criteria: - Patients with mixed tumors of small cell features - Known infection with HIV, hepatitis B or hepatitis C - Baseline prolongation of QT/QTcF interval or required concomitant medication that may cause Torsade de Pointes - Preexisting =Grade 2 neuropathy - Valproic acid treatment within 2 weeks of study enrollment - Systemic steroids, for any indication, stabilized at >10 mg/day prednisone - Known allergy or hypersensitivity to any component of belinostat, paclitaxel or carboplatin - Co-existing active infection or any other uncontrolled medical condition likely to interfere with trial procedures - Active concurrent malignancy (except basal cell carcinoma or cervical intraepithelial neoplasia, other potentially cured malignancy that has been in remission for five years or prior adjuvant therapy for early stage lung cancer that is completed = 12 months ago) - Pregnant or breast-feeding women |
Country | Name | City | State |
---|---|---|---|
United States | University Cancer Insitute | Boynton Beach | Florida |
United States | Clearview Cancer Institute (CCI) | Huntsville | Alabama |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Sarcoma Oncology Center | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Acrotech Biopharma LLC | Onxeo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the Maximum Tolerated Dose ( MTD) of belinostat in combination with carboplatin and paclitaxel in patient with Stage IV non-small cell lung cancer who has received no prior systemic chemotherapy. | At study entry each eligible patient will be assigned a specific dose level and dose of IV belinostat in mg/m2, to be administered daily on Days 1 to 5 each 21 day cycle, for up to 6 cycles. Dose escalation within each patient is not allowed during this study. At each dose level cohort of up to 6 patients may be evaluated during Cycle 1 of therapy. Multiple dose levels may be evaluated to determine the Maximum Tolerated Dose (MTD) of IV belinostat, in combination with 6 cycles of IV carboplatin and paclitaxel, for chemo-naïve patients with Stage IV NSCLC. | 24 Months | |
Secondary | Safety and Tolerability when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC. | Safety will be based on treatment emergent adverse events (TEAEs), including DLTs will be graded by CTCAE version 4.02, and grouped by the MedDRA preferred term, and summarized by worst grade severity per patient. TEAEs are those adverse events that occur or worsen on or after first study treatment up through 30 days post last study treatment, and/or any treatment-related. Tolerability will be mainly characterized by the number and severity of treatment emergent adverse events, and treatment related AEs that occur or worsen after the first dose of study treatment. Deaths, non-fatal serious adverse events (SAEs), and other AEs leading to discontinuation of study treatment will be summarized. | 24 Months | |
Secondary | Efficacy when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC | Efficacy variable of this study is best overall response, using RECIST criteria - complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), and not evaluable (NE) - as determined by the investigator.The efficacy endpoint is objective response rate (ORR), defined as the proportion of patients with target lesions who achieve either a CR or a PR. | 24 Months | |
Secondary | Progression-free survival (PFS) when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC | progression-free survival (PFS) will be analyzed, defined as the duration of time from date of first study treatment to date of first documented progression or death from any cause. All treated patients will be included in the analysis of PFS. Patients without a documented progression or death will be censored at the last disease assessment. | 24 Months | |
Secondary | Objective response rate (ORR) when IV belinostat is administered in combination with carboplatin and paclitaxel in patients with chemotherapy naïve Stage IV M1a or M1b NSCLC. | The efficacy endpoint is objective response rate (ORR), defined as the proportion of patients with target lesions who achieve either a CR or a PR. A two-sided exact 95% confidence. interval (CI) will be calculated for ORR. For example, if 24 patients are to be treated, including 20 patients with target lesions at baseline, and 8 patient achieve a CR or a PR, then the response rate will be 40% with a 95% CI of [19%, 64%]. |
24 Months |
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