Back to resultsPhase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Primary Purpose
Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SN2310 Injectable Emulsion
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
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
Sites / Locations
- Fox Chase Cancer Center
- Sarah Cannon Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
SN2310 Injectable Emulsion
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Dose-Limiting Toxicity
Adverse Events
Pharmacokinetic parameters for SN2310 and SN-38
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385177
Brief Title
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Official Title
A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Achieve Life Sciences
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Pelvic Neoplasms, Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
SN2310 Injectable Emulsion
Intervention Type
Drug
Intervention Name(s)
SN2310 Injectable Emulsion
Intervention Description
Escalating doses given IV every three weeks
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
December 2008
Title
Dose-Limiting Toxicity
Time Frame
December 2008
Title
Adverse Events
Time Frame
December 2008
Title
Pharmacokinetic parameters for SN2310 and SN-38
Time Frame
December 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
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