Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Triphase Research and Development I Corporation
• Treatments: Dexamethasone; Proteasome Inhibitors

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.