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| Sponsor: | Semafore Pharmaceuticals |
|---|---|
| Information provided by: | Semafore Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00907205 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of SF1126 in patients with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and defining the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced or Metastatic Solid Tumors Cancer Solid Cancers |
Drug: SF1126 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Open Label Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of SF1126, A PI3 Kinase (PI3K) Inhibitor, Given Twice Weekly By IV Infusion To Patients With Advanced or Metastatic Tumors |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SF1126
Twice weekly IV infusion
|
Drug: SF1126
Dose Escalating with 3+ patients in each cohort
Other Name: SF1126
|
SF1126 is a conjugate containing a vascular targeted pan-PI3K inhibitor that selectively inhibits all PI3K class I isoforms and other key members of the PI3K superfamily, including mTORC1/2, DNA-PK, PLK-1, CK2, ATM and PIM-1. SF1126 is designed to inhibit both angiogenesis and cell proliferation by targeting and binding to specific integrins such as αγβ3 that are expressed on the surface of new tumor vasculature and within the tumor compartment. In preclinical xenograft models SF1126 has demonstrated broad activity as a single agent; synergy with commonly used chemotherapy agents, targeted agents, and radiation; and has been shown to reverse resistance mediated through the PI3K/PTEN pathway.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To qualify for enrollment, all of the following criteria must be met:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Scottsdale Clinical Research Institute | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Cathy Costanza, RN, BS, OCN 480-323-1550 ccostanza@shc.org | |
| Contact: Jennifer Privratsky 480-323-1591 jprivratsky@shc.org | |
| Principal Investigator: Ramesh Ramanathan, MD | |
| Arizona Cancer Center | Recruiting |
| Tucson, Arizona, United States, 85719 | |
| Contact: Diane Rensvold, RN 520-694-9055 drensvold@azcc.arizona.edu | |
| Contact: Judy Safarewitz, RN 520-694-9058 jsafarewitz@azcc.arizona.edu | |
| Principal Investigator: Daruka Mahadevan, MD | |
| United States, Georgia | |
| Emory Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Almelida Rene Merrieweather 404-778-1802 amerrie@emory.edu | |
| Contact: Donald Harvey, PhD 404-778-4381 donald.harvey@emoryhealthcare.org | |
| Principal Investigator: Wayne Harris, MD | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Mary Jane Waddell, RN, CCRC 317-274-7119 mjwaddell@iupui.edu | |
| Contact: Jennifer M Funke, MS 317-278-0328 jmfunke@iupui.ed | |
| Principal Investigator: E. Gabriela Chiorean, MD | |
| Study Chair: | Joseph Garlich, PhD | Semafore Pharmaceuticals |
More Information
| Responsible Party: | Joseph Garlich, PhD, Semafore Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00907205 History of Changes |
| Other Study ID Numbers: | SF1126-001-06 |
| Study First Received: | May 20, 2009 |
| Last Updated: | May 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced Solid Tumors Metastatic Solid Tumors PI3K PI3K Inhibitors PI3 Kinase Inhibitors |
mTORC inhibitor mTORC1 inhibitor mTORC2 inhibitor vascular targeted conjugate |
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Neoplasms |