Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors

Sponsor
Achieve Life Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT00385177
Collaborator
(none)
61
2
1
32
30.5
1

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
  • Drug: SN2310 Injectable Emulsion
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

Study Type:
Interventional
Anticipated Enrollment :
61 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
May 1, 2009

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

  1. Maximum Tolerated Dose [December 2008]

  2. Dose-Limiting Toxicity [December 2008]

  3. Adverse Events [December 2008]

  4. Pharmacokinetic parameters for SN2310 and SN-38 [December 2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00385177
Other Study ID Numbers:
  • SON-2310-06-101
First Posted:
Oct 6, 2006
Last Update Posted:
Jun 4, 2009
Last Verified:
Jun 1, 2009

Study Results

No Results Posted as of Jun 4, 2009