Phase 1 Clinical Trial in Patients With Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier:
NCT00629473
First received: February 26, 2008
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with advanced malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.


Condition Intervention Phase
Advanced Malignancies
Drug: NPI 0052
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Triphase Research and Development I Corporation:

Primary Outcome Measures:
  • To determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI 0052 when administered via IV injection on Days 1, 8, 15 during a four week cycle for patients with advanced malignancies [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics, toxicity profile, biological activity, pharmacodynamics and anti-tumor activity of NPI-0052 in patients with these malignancies. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: July 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advan. malignancies
IV injection of NPI-0052
Drug: NPI 0052
IV injection
Other Name: proteasome inhibitor
Experimental: multiple myeloma
IV injection of NPI-0052
Drug: NPI 0052
IV injection
Other Name: proteasome inhibitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky Performance Status (KPS) > 70%.
  • Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available.
  • Adequate renal, liver, pancreatic and hematologic function
  • Signed informed consent (sample IC form is provided in Appendix A).

Exclusion Criteria

  • Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days
  • Patients that require G-CSF and/or platelet support during screening and are likely to require G-CSF and/or platelet support for the duration of the clinical trial.
  • Patients with ongoing coagulopathies and/or taking anticoagulants
  • Patients receiving intrathecal therapy.
  • Known brain metastases.
  • Pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. Pre-existing acute or chronic pancreatitis.
  • Significant cardiac disease.
  • Pregnant or breast-feeding women.
  • Concurrent, active secondary malignancy for which the patient is receiving therapy. (Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are without evidence of disease for this second malignancy may continue to receive hormonal therapy).
  • Patients with proteinuria Grade 2 or greater
  • Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
  • Patients who are known to be HIV positive or have active Hepatitis A, B, or C infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629473

Locations
Australia, Queensland
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5001
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3168
Peter MacCallum Cancen Center
Melbourne, Victoria, Australia, 3002
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Sir Charles Gairdner Hospital and University of Western Australia
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Triphase Research and Development I Corporation
Investigators
Study Director: Robert Corringham, MD Triphase Research and Development I Corp, Chief Medical Officer
  More Information

No publications provided

Responsible Party: Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier: NCT00629473     History of Changes
Other Study ID Numbers: NPI 0052-102
Study First Received: February 26, 2008
Last Updated: May 23, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Triphase Research and Development I Corporation:
multiple myeloma
leukemias (inc. CLL)
lymphomas
cutaneous lymphoma
marginal zone lymphoma
advanced malignancies without standard treatment options

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014