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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)

Phase 1/Phase 2
18 Years
Open (Enrolling)
Stage IV Non-small Cell Lung Cancer

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Trial Information

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)

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Brian Matthews, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clearview Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Stage IV Non-Small Cell Lung Cancer
  • Phase 1/2
  • MTD
  • stage IV
  • chemo-naive
  • Mixed-cell dose escalation
  • lung cancer
  • non-small-cell
  • phase I
  • Belinostat
  • Carboplatin
  • Paclitaxel
  • adenocarcinoma
  • PXD-101
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110
Yale Cancer Center New Haven, Connecticut  06520-8028
Tower Cancer Research Foundation Beverly Hills, California  90211
Lakeland Regional Cancer Center Lakeland, Florida  33805
California Pacific Medical Center San Francisco, California  94115
Sarcoma Oncology Center Santa Monica, California  90403
Clearview Cancer Institute (CCI) Huntsville, Alabama  35805
University Cancer Insitute Boynton Beach, Florida  33426