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| Sponsor: | CytRx |
|---|---|
| Information provided by: | CytRx |
| ClinicalTrials.gov Identifier: | NCT00352677 |
Purpose
The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia Acute Lymphocytic Leukemia |
Drug: INNO-406 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Germany | |
| Charite University of Medicine | |
| Berlin, Germany, 13353 | |
| Johann Wolfgang Goethe Universität | |
| Frankfurt am Main, Germany, 60590 | |
| University of Heidelberg Medical Clinic | |
| Mannheim, Germany, 68305 | |
| Israel | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Principal Investigator: | Hagop Kantarjian, M.D. | University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org |
More Information
| Responsible Party: | Michael Dowd, Director, Product Development, Innovive Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00352677 History of Changes |
| Other Study ID Numbers: | INNO-406 |
| Study First Received: | July 14, 2006 |
| Last Updated: | May 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes |