Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma

Completed · Phase 1

Conditions studied: Cancer, Lymphomas

In brief

Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies or refractory lymphoma whose disease had progressed after treatment with standard, approved therapies that included 2 stages. The initial stage involved dose escalation to an MTD and determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort at the recommended Phase 2 dose.

Key facts

Study ID

NCT00396864

Run by

Celgene

People needed

51

Starts

2006-05-01

Expected to finish

2010-03-01

Last updated by the study team

2017-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Premiere Oncology of America — Scottsdale, Arizona, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Univ. of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.