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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma, Lymphoma, Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat

Outcome Time Frame:

continuously

Safety Issue:

Yes

Principal Investigator

Robert Corringham, MD

Investigator Role:

Study Director

Investigator Affiliation:

Triphase Research and Development I Corp, Chief Medical Officer

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

NPI-0052-103

NCT ID:

NCT00667082

Start Date:

March 2008

Completion Date:

January 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Melanoma
  • Lymphoma
  • Multiple Myeloma
  • Non small Cell Lung Cancer
  • Pancreatic Cancer
  • Melanoma
  • Lymphoma
  • Multiple Myeloma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Lymphoma
  • Melanoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Pancreatic Neoplasms

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