Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
This study has been completed.
Information provided by (Responsible Party):
Triphase Research and Development I Corporation
First received: November 6, 2006
Last updated: August 11, 2014
Last verified: August 2014
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 refractory solid tumors or lymphomas. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
Primary Outcome Measures:
- Safety [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
- Maximum Tolerated Dose (MTD) [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacodynamics [ Time Frame: Continuous ] [ Designated as safety issue: No ]
- Response [ Time Frame: Continous ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2010 (Final data collection date for primary outcome measure)
Advanced Solid Tumor Malignancies and Refractory Lymphoma
IV injection, three times every 28 days, escalating dosing cohorts
Other Name: Marizomib
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) OR refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-CD20 monoclonal antibody-containing regimen.
- KPS ≥70%.
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade ≤ 1 (except for hemoglobin).
- Adequate bone marrow, renal, adrenal, pancreatic and liver function.
- Signed informed consent.
- Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. Radiotherapy within 4 weeks.
- Patients that require G-CSF and/or platelet support.
- Patients with ongoing coagulopathies.
- Patients with prior bone marrow transplant therapy (autologous or allogeneic).
- Patients receiving intrathecal therapy.
- Known brain metastases.
- Significant cardiac disease.
- Patients with a prior hypersensitivity reaction of CTCAE Grade ≥ 3 to therapy containing propylene glycol or ethanol.
- Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
- Concurrent, active secondary malignancy for which the patient is receiving therapy.
- Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
- Known to be positive for HIV; active hepatitis A, B, or C infection.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396864
|Memorial Sloan-Kettering Cancer Center
|New York, New York, United States, 10021 |
|Univ. of Texas MD Anderson Cancer Center
|Houston,, Texas, United States, 77030 |
Triphase Research and Development I Corporation
||Steven D Reich, MD
||Triphase Research and Development I Corp
No publications provided
||Triphase Research and Development I Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 6, 2006
||August 11, 2014
||United States: Food and Drug Administration
Keywords provided by Triphase Research and Development I Corporation:
marginal zone lymphoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Immune System Diseases
Neoplasms by Histologic Type