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)
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).
Stage IV Non-small Cell Lung Cancer
Drug: Belinostat, Carboplatin, Paclitaxel
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Maximum Tolerated Dose (MTD) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]Safety 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.
- Efficacy [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Efficacy will be evaluated by measuring time to progression from first dose (PFS), and calculating the proportion of patients who achieve either CR or PR (ORR) using RECIST criteria.
- Tolerability [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Single arm, open label||
Drug: Belinostat, Carboplatin, Paclitaxel
Up to 6 cycles of combination therapy of belinostat plus carboplatin (AUC 6) and paclitaxel 200 mg/m2. Initial dose of belinostat will be 1000mg/m2 for MTD dose escalation evaluation.
Other Name: PXD-101
This is a Phase 1/2, multi-center, open label single arm study. Patients meeting all inclusion and exclusion criteria will receive up to 6 cycles of combination therapy of belinostat plus carboplatin (AUC 6) and paclitaxel 200 mg/m2.
During phase I the Maximum Tolerated Dose (MTD) of belinostat in combination with carboplatin and paclitaxel will be determined in patients with Stage IV non-small cell lung cancer who have received no prior systemic chemotherapy. The dose escalation study will be conducted using traditional escalation rule of 3+3 design, during the first cycle of therapy. Belinostat will be assessed at a starting dose level of 1000 mg/m2 and multiple dose levels may be evaluated. Doses of belinostat, carboplatin and paclitaxel will remain constant throughout the study, unless dose modification is required by toxicity. Treatment is given on days 1-5 of every 21-day cycle. Routine safety evaluations will be conducted on days, 1, 8, and 15 of every cycle. Tumor measurement will be done after every 2 cycles of the treatment.
Additional 20 patients will be treated at the MTD defined dose during phase II expansion portion of the study.
All patients will receive up to 6 cycles of combination therapy and be followed until occurrence of unacceptable toxicity, disease progression, withdrawal of consent or death.
|Contact: Show-Li Sun, MD||949-743-9267|
|United States, Alabama|
|Clearview Cancer Institute (CCI)||Recruiting|
|Huntsville, Alabama, United States, 35805|
|Contact: Brian Mathews, MD 256-705-4224 email@example.com|
|Contact: Leslie Smoot, RN 256-705-4246 firstname.lastname@example.org|
|Principal Investigator: Brian Matthews|
|United States, California|
|Tower Cancer Research Foundation||Withdrawn|
|Beverly Hills, California, United States, 90211-1850|
|California Pacific Medical Center||Withdrawn|
|San Francisco, California, United States, 94115|
|Sarcoma Oncology Center||Recruiting|
|Santa Monica, California, United States, 90403|
|Contact: Sant Chawla, MD 310-552-9999|
|Principal Investigator: Sant Chawla, MD|
|United States, Connecticut|
|Yale Cancer Center||Withdrawn|
|New Haven, Connecticut, United States, 06520|
|United States, Florida|
|University Cancer Insitute||Recruiting|
|Boynton Beach, Florida, United States, 33426|
|Principal Investigator: Thomas Neiderman, MD|
|Lakeland Regional Cancer Center||Recruiting|
|Lakeland, Florida, United States, 33805|
|Principal Investigator: Sushma Nakka, MD|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator: Saiama Waqar, MD|
|Principal Investigator:||Brian Matthews, MD||Clearview Cancer Institute|
|Principal Investigator:||Sant Chawla, MD||Sarcoma Oncology Center|
|Principal Investigator:||Saiama Waqar, MD||Washington University School of Medicine|
|Principal Investigator:||Thomas Neiderman, MD||University Cancer Insitute|