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NCT00667082 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00667082
Other study ID # NPI-0052-103
Secondary ID
Status Completed
Phase Phase 1
First received April 22, 2008
Last updated November 20, 2017
Start date March 2008
Est. completion date January 2010

Study information
Verified date November 2017
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NPI-0052 (marizomib) + vorinostat
NPI-0052 IV injection over 1 to 10 minutes at doses ranging from 0.15 to 0.7 mg/m2 on Days 1, 8, and 15 of each 28-day Cycle Oral vorinostat 300 mg was administered with food on Days 1 to 16 of each 28-day Cycle

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Sir Charles Gairdner Hospital and University of Western Australia Nedlands Western Australia
Australia The Queen Elizabeth Hospital Woodville South South Australia

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat continuously
Secondary To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat continuous
Secondary To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat continuous
Secondary To evaluate the anti-tumor activity of NPI-0052 and vorinostat continuous
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