Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma
This study has been completed.
Information provided by:
Nereus Pharmaceuticals, Inc.
First received: May 4, 2006
Last updated: January 6, 2011
Last verified: January 2011
This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the vascular disrupting agent NPI-2358 in patients with refractory solid tumors or lymphoma. The formation of new blood vessels (angiogenesis) is an important component of tumor growth and vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. NPI-2358 has also been seen to directly affect tumor cells.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Study of the Vascular Disrupting Agent NPI-2358 Administered Via Intravenous Infusion in Patients With Advanced Solid Tumor Malignancies or Lymphoma
Primary Outcome Measures:
- Safety [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
- Tolerability [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose (MTD) [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: continuously ] [ Designated as safety issue: No ]
- Pharmacodynamics [ Time Frame: continuously ] [ Designated as safety issue: No ]
- Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: continuously ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
Experimental: Dose escalation
Treatment on Days 1, 8 and 15 in a 28 day cycle
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- ECOG performance status ≤ 2
- Pathologically or histologically confirmed solid tumor malignancy
- Patients must not be candidates for regimens known to provide clinical benefit.
- All adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v. 3.0) Grade ≤ 2, except for neurological toxicity that must have resolved to Grade ≤ 1.
- Adequate bone marrow reserve, hepatic and renal function
- Signed informed consent
- Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 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 6 weeks before first study drug administration. Radiotherapy within 4 weeks (some types of radiation therapy are excluded regardless of interval since treatment).
- Significant cardiac history or findings
- Underlying conditions or medications associated with bleeding diathesis
- Disorders associated with significant vascular pathology
- Lung cancer with central chest tumors
- Prior treatment with vascular disruptive agents
- Seizure disorder requiring anticonvulsant therapy; prior transient ischemic attack or cerebrovascular accident
- Brain metastases
- Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
- Known infection with human immunodeficiency virus (HIV), active hepatitis A, B, or C
- Patients with a prior hypersensitivity reaction to any product containing Solutol and/or propylene glycol
- 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 second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322608
|Barbara Ann Karmanos Cancer Institute/Wayne State University
|Detroit, Michigan, United States, 48201 |
|Institute for Drug Development
|San Antonio, Texas, United States, 78245-3217 |
|Northwest Medical Specialties
|Tacoma, Washington, United States, 98405 |
Nereus Pharmaceuticals, Inc.
||Matthew A Spear, M.D.
||Chief Medical Officer, Nereus Pharmaceuticals, Inc.
No publications provided
||Kristine C. Federico RN,BSN, Nereus Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 4, 2006
||January 6, 2011
||United States: Food and Drug Administration
Keywords provided by Nereus Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Neoplasms by Histologic Type
Immune System Diseases