Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A SN2310 Injectable Emulsion |
Drug: SN2310 Injectable Emulsion
Escalating doses given IV every three weeks
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose [December 2008]
- Dose-Limiting Toxicity [December 2008]
- Adverse Events [December 2008]
- Pharmacokinetic parameters for SN2310 and SN-38 [December 2008]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists
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ANC > 1,500 cell/mm3, platelets > 100,000/mm3 and Hgb > 9 g/dl
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At least one unidimensionally measurable lesion per RECIST
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Negative serum or urine pregnancy test, if female of childbearing potential
Exclusion Criteria:
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Female who is pregnant or lactating
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History of chronic diarrhea
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
2 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- Achieve Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SON-2310-06-101