Status:
COMPLETED
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Lead Sponsor:
Achieve Life Sciences
Conditions:
Breast Neoplasms
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 intr...
Eligibility Criteria
Inclusion
- 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
- Female who is pregnant or lactating
- History of chronic diarrhea
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00385177
Start Date
September 1 2006
End Date
May 1 2009
Last Update
June 4 2009
Active Locations (2)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
2
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203