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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma LLC; Spectrum Pharmaceuticals, Inc
• Collaborator: Onxeo
• Treatments: Albumin-Bound Paclitaxel; Belinostat; Carboplatin; Paclitaxel

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