Proteasome Inhibitor NPI-0052 and Vorinostat in Patients With Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma

Original Study ID : NPI-0052-103

NCT ID : NCT00667082

Brief Title : Proteasome Inhibitor NPI-0052 and Vorinostat in Patients With Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma

Official Title : NPI-0052 and Vorinostat in Patients With Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma

Brief Summary :

This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.

Source : Nereus Pharmaceuticals, Inc.

Overall Status : Recruiting

Start Date : March 2008

End Date : September 2009

Completion Date : September 2009

Official Title : Phase 1

Phase : Interventional

Study Design : Other, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Enrollment : 40

Verification Date : October 2008

First Received Date : April 22, 2008

Trial Eligibility

Criteria :
Inclusion Criteria:

1. Karnofsky Performance Status (KPS) at 70% or more.

2. Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which
a standard, approved therapy is not available. Patients must have lesions that are
evaluable by RECIST criteria.

3. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have
resolved to CTCAE (v. 3.0) Grade 1 or less(except for hemoglobin).

4. Adequate bone marrow, renal, liver function.

5. Signed informed consent.

Exclusion Criteria:

1. Recent administration of chemotherapy, biological, immunotherapy or investigational
agent, major surgery, or radiotherapy.

2. Intrathecal therapy.

3. Known brain metastases.

4. Significant cardiac disease.

5. Prior treatment with vorinostat or NPI-0052, or other HDACi (including valproic acid)
or proteasome inhibitors.

6. Known allergy to any component of vorinostat. Prior hypersensitivity reaction of
CTCAE Grade > 3 to therapy containing propylene glycol or ethanol.

7. Pregnant or breast-feeding women.

8. Concurrent, active secondary malignancy for which the patient is receiving therapy.

9. Significant active infection.

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : The Queen Elizabeth Hospital

Status : Recruiting

City : Woodville South

State : South Australia

Zip Code : 5011

Country : Australia

Facility Name : Royal Adelaide Hospital

Status : Recruiting

City : Adelaide

State : South Australia

Zip Code : 5000

Country : Australia

Facility Name : Sir Charles Gairdner Hospital and University of Western Australia

Status : Recruiting

City : Nedlands

State : Western Australia

Zip Code : 6009

Country : Australia

OutComes

Primary OutComes

Secondary OutComes

Measure : To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat

Time Frame : continuous

Safety issue : Yes

Measure : To evaluate the anti-tumor activity of NPI-0052 and vorinostat

Time Frame : continuous

Safety issue : No

Interventions

Type : Drug

Name : NPI-0052 + vorinostat

Description : NPI-0052 IV weekly vorinostat oral daily

Clinical Trial Name - Proteasome Inhibitor NPI-0052 and Vorinostat in Patients With Non-Small Cell Lung Cancer, Pancreat