Trial record 1 of 1 for:
NCT01310244
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)
This study is currently recruiting participants.
Verified April 2013 by Spectrum Pharmaceuticals, Inc
Sponsor:
Spectrum Pharmaceuticals, Inc
Collaborator:
TopoTarget A/S
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01310244
First received: February 28, 2011
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Non-small Cell Lung Cancer |
Drug: Belinostat, Carboplatin, Paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Further study details as provided by Spectrum Pharmaceuticals, Inc:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 35 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310244
Contacts
| Contact: Show-Li Sun, MD | 949-743-9267 |
Locations
| United States, Alabama | |
| Clearview Cancer Institute (CCI) | Recruiting |
| Huntsville, Alabama, United States, 35805 | |
| Contact: Brian Mathews, MD 256-705-4224 bmathews@ccihsv.com | |
| Contact: Leslie Smoot, RN 256-705-4246 leslies@ccihsv.com | |
| 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 | |
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
TopoTarget A/S
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Spectrum Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01310244 History of Changes |
| Other Study ID Numbers: | SPI-1014-Bel |
| Study First Received: | February 28, 2011 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Spectrum Pharmaceuticals, Inc:
|
Phase 1/2 MTD stage IV NSCLC chemo-naive Mixed-cell dose escalation lung cancer |
non-small-cell phase I Belinostat Carboplatin Paclitaxel adenocarcinoma PXD-101 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013