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NCT Number: NCT00385177

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. 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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pelvic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SN2310 Injectable Emulsion

Drug

Escalating doses given IV every three weeks

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: December 2008

  2. Dose-Limiting Toxicity

    Time frame: December 2008

  3. Adverse Events

    Time frame: December 2008

  4. Pharmacokinetic parameters for SN2310 and SN-38

    Time frame: December 2008

Sponsors and collaborators

Lead sponsor

Achieve Life Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Oct 6, 2006
Registry last updated
Jun 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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