Clinical trial · Interventional
MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC
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)
NCT01310244CI-TRIAL-00042589completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belinostat, Carboplatin, Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm, open label
- description
- At the study entry each patient will receive a dose level assignment which will include a specific dose level and the dose of IV belinostat in mg/m2 to be administered during the study treatment. Belinostat will be infused over 30 minutes once daily on Days 1-5 of each 21-day cycle. On Day 3, the infusion of belinostat must be completed at least 1 hour prior to the start of the paclitaxel infusion. Dose of belinostat will be assigned at study entry. The same dose and level will remain throughout the entire study for each patient and no dose adjustment will be allowed, except due to toxicity.
- interventionNames
- Drug: Belinostat, Carboplatin, Paclitaxel
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 24 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.