NPI-0052 And Vorinostat In Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma Or Lymphoma

Study Overview

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

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.

N/A

Non-Small Cell Lung Cancer
Pancreatic Cancer
Melanoma
Lymphoma
Multiple Myeloma

DRUG: NPI-0052 (marizomib) + vorinostat

NPI-0052-103

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-04-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-11-20
First Submitted that Met QC Criteria 2008-04-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-11-22
First Posted (ACTUAL) 2008-04-25	Results First Posted N/A	Last Verified 2017-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: NPI-0052 + Vorinostat Dose-Escalation 4 dose-escalation cohorts	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: NPI-0052 + Vorinostat Dose-Escalation

4 dose-escalation cohorts

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

Primary Outcome Measures	Measure Description	Time Frame
To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat		continuously

Secondary Outcome Measures	Measure Description	Time Frame
To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat		continuous
To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat		continuous
To evaluate the anti-tumor activity of NPI-0052 and vorinostat		continuous

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Steven D Reich, MD, Triphase Research and Development I Corp

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record