MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC

Completed · Phase 1/Phase 2

Conditions studied: Stage IV Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT01310244

Run by

Acrotech Biopharma Inc.

People needed

23

Starts

2010-12-01

Expected to finish

2015-08-01

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clearview Cancer Institute (CCI) — Huntsville, Alabama, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• University Cancer Insitute — Boynton Beach, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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