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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00866281 |
Purpose
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia |
Drug: midostaurin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Open-label, Dose-escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Twice Daily Oral Midostaurin and to Evaluate the Preliminary Clinical and Pharmacodynamic Response in Pediatric Patients With Relapsed or Refractory Leukemia |
| Estimated Enrollment: | 22 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Midostaurin |
Drug: midostaurin
Other Name: PKC412
|
Eligibility| Ages Eligible for Study: | 3 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Novartis Pharmaceuticals | +1 800 340 6843 |
| United States, California | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868-3874 | |
| Contact: Cheryl Willis 714-532-8824 cwillis@choc.org | |
| Contact: Laura Gates +1-714-532-8824 lgates@choc.org | |
| Principal Investigator: Steven Neudorf, M.D. | |
| United States, Illinois | |
| Children's Memorial Hospital | Not yet recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Jennifer Dino 773-880-4956 jdino@childrensmemorial.org | |
| Principal Investigator: Nobuko Hijiya, M.D. | |
| United States, Massachusetts | |
| Dana Faber Cancer Institute, Children's Hospital, Dept. of Pediatric Oncology | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Jane E. O'Brien, CCRP 617-632-3549 jane_obrien@dfci.harvard.edu | |
| Principal Investigator: Lewis Silverman, M.D. | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Sara Muchinsky 206-884-1591 Sara.muchinsky@seattlechildrens.org | |
| Principal Investigator: Blythe Thomson, M.D. | |
| France | |
| Novartis Investigative Site | Recruiting |
| Lyon, France | |
| Novartis Investigative Site | Recruiting |
| Paris, France | |
| Italy | |
| Novartis Investigative Site | Recruiting |
| Genova, Italy | |
| Novartis Investigative Site | Recruiting |
| Monza, Italy | |
| Novartis Investigative Site | Recruiting |
| Rome, Italy | |
| Novartis Investigative Site | Recruiting |
| Torino, Italy | |
| Netherlands | |
| Novartis Investigative Site | Recruiting |
| Rotterdam, Netherlands | |
| Sweden | |
| Novartis Investigative Site | Recruiting |
| Stockholm, Sweden | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00866281 History of Changes |
| Other Study ID Numbers: | CPKC412A2114, EudraCT number 2008-006931-11 |
| Study First Received: | March 19, 2009 |
| Last Updated: | March 18, 2011 |
| Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Netherlands: Ministry of Health, Welfare and Sport |
|
Acute Myeloid Leukemia AML Acute Lymphoblastic Leukemia ALL |
midostaurin PKC412 Pediatric relapsed or refractory FLT3 positive Acute Myeloid Leukemia Pediatric relapsed or refractory Mixed-lineage leukemia gene rearranged Acute Lymphoblastic leukemia |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases 4'-N-benzoylstaurosporine Staurosporine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |