A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
18 Years
N/A
Both
Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Pelvic Neoplasms, Lung Neoplasms
Trial Information
A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced
solid malignancies who have failed conventional therapy. SN2310 Injectable Emulsion will be
administered intravenously every 21 days. The study is designed to determine the maximum
tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion; to characterize the
pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310
Injectable Emulsion; to evaluate side effects as a function of dose level; and, to observe
any anti-tumor effects of SN2310 Injectable Emulsion.
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of solid tumor with disease
progression despite standard therapy and/or for which no other solid therapeutic
option exists
- ANC > 1,500 cell/mm3, platelets > 100,000/mm3 and Hgb > 9 g/dl
- At least one unidimensionally measurable lesion per RECIST
- Negative serum or urine pregnancy test, if female of childbearing potential
Exclusion Criteria:
- Female who is pregnant or lactating
- History of chronic diarrhea
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose
Outcome Time Frame:
December 2008
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
SON-2310-06-101
NCT ID:
NCT00385177
Start Date:
September 2006
Completion Date:
May 2009
Related Keywords:
- Breast Neoplasms
- Colorectal Neoplasms
- Pancreatic Neoplasms
- Pelvic Neoplasms
- Lung Neoplasms
- Breast Neoplasms
- Neoplasms
- Colorectal Neoplasms
- Lung Neoplasms
- Pancreatic Neoplasms
- Pelvic Neoplasms
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
