Invivoscribe’s clinical trials program in hematology oncology is focused
on diagnostic testing of biomarkers and regulatory approval of
companion diagnostic products.
Development and Validation of Diagnostic Products
Invivoscribe strives to stay ahead of the curve with development and
validation of diagnostic products that assist in the development of
therapeutic products that target our IP protected biomarkers, from
pre-clinical research to post-marketing studies.
IVS is committed to transparency in medical
research. All of our active, company involved clinical trials are
listed on the National Institutes of Health Web site
www.clinicaltrials.gov. We list this information here on our site, as
well.
Currently, we include results for FLT3-ITD
diagnostic products, and we are working to gather and add results for
several more products over the coming months.
Clinical Trials
Below are
summaries of and links to the clinical trials which include TKIs
targeting FLT3. The clinical trials listed are currently
accepting new patients or soon will be.
| Trial Name: |
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML) (ACE)
|
| ClinicalTrials.gov Identifier: |
NCT00989261 |
| Trial Phase |
II |
| Tyrosine Kinase Inhibitor, Manufacturer |
AC220, Ambit Biosciences |
| Principal Investigator/s; Institution/s: |
Robert Corringham, MD; Ambit Biosciences Corporation |
| FLT3 Variation Required for Study Enrollment? |
Yes |
|
| Trial Name: |
Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
|
| ClinicalTrials.gov Identifier: |
NCT00943943 |
| Trial Phase |
I |
| Tyrosine Kinase Inhibitor, Manufacturer |
Sorafenib (BAY 43-9006), Bayer |
| Principal Investigator/s; Institution/s: |
Michael Andreeff, MD, PhD; M.D. Anderson Cancer Center |
| FLT3 Variation Required for Study Enrollment? |
Yes |
|
| Trial Name: |
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
|
| ClinicalTrials.gov Identifier: |
NCT00866281 |
| Trial Phase |
I & II |
| Tyrosine Kinase Inhibitor, Manufacturer |
Midostaurin (PKC412), Novartis |
| Principal Investigator/s; Institution/s: |
Novartis Pharmaceuticals |
| FLT3 Variation Required for Study Enrollment? |
No |
|
| Trial Name: |
Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years
|
| ClinicalTrials.gov Identifier: |
NCT00783653 |
| Trial Phase |
I & II |
| Tyrosine Kinase Inhibitor, Manufacturer |
Sutent (Sunitinib/SU 11248), Pfizer |
| Principal Investigator/s; Institution/s: |
Walter Fiedler; Universitätsklinikum Hamburg-Eppendorf |
| FLT3 Variation Required for Study Enrollment? |
Yes |
|
| Trial Name: |
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia (AML) |
| ClinicalTrials.gov Identifier: |
NCT00779480 |
| Trial Phase |
I & II |
| Tyrosine Kinase Inhibitor, Manufacturer |
KW-2449, Kyowa Pharmaceutical |
| Principal Investigator/s; Institution/s: |
Terry F. Plasse; Kyowa Pharmaceutical |
| FLT3 Variation Required for Study Enrollment? |
Yes |
|
| Trial Name: |
Danorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
|
| ClinicalTrials.gov Identifier: |
NCT00651261 |
| Trial Phase |
III |
| Tyrosine Kinase Inhibitor, Manufacturer |
Midostaurin (PKC412), Novartis |
| Principal Investigator/s; Institution/s: |
Richard M. Stone, MD; Dana-Farber Cancer Institute |
| FLT3 Variation Required for Study Enrollment? |
Yes |
|
| Trial Name: |
Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
|
| ClinicalTrials.gov Identifier: |
NCT00343694 |
| Trial Phase |
I |
| Tyrosine Kinase Inhibitor, Manufacturer |
Sorafenib (BAY 43-9006), Bayer |
| Principal Investigator/s; Institution/s: |
Brigitte C. Widemann, MD; NCI - Pediatric Oncology Branch |
| FLT3 Variation Required for Study Enrollment? |
No |
|
| Trial Name: |
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
| ClinicalTrials.gov Identifier: |
NCT00522990 |
| Trial Phase |
I & II |
| Tyrosine Kinase Inhibitor, Manufacturer |
AT9283, Astex Therapeutics |
| Principal Investigator/s; Institution/s: |
Hagop Kantarjian; M.D. Anderson Cancer Center |
| FLT3 Variation Required for Study Enrollment? |
No |
|
| Trial Name: |
RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
|
| ClinicalTrials.gov Identifier: |
NCT00819546 |
| Trial Phase |
I |
| Tyrosine Kinase Inhibitor, Manufacturer |
Midostaurin (PKC412), Novartis |
| Principal Investigator/s; Institution/s: |
Richard Stone, MD; Dana-Farber Cancer Institute |
| FLT3 Variation Required for Study Enrollment? |
No |
|
| Trial Name: |
Sorafenib and Cytarabine in Treating Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
|
| ClinicalTrials.gov Identifier: |
NCT00516828 |
| Trial Phase |
I & II |
| Tyrosine Kinase Inhibitor, Manufacturer |
Sorafenib (BAY 43-9006), Bayer |
| Principal Investigator/s; Institution/s: |
Brian Leber, MD, FRCPC, McMaster Children's Hospital
David A. MacDonald, MD, Nova Scotia Cancer Centre |
| FLT3 Variation Required for Study Enrollment? |
No |
|
| Trial Name: |
Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia
|
| ClinicalTrials.gov Identifier: |
NCT00217646 |
| Trial Phase |
I |
| Tyrosine Kinase Inhibitor, Manufacturer |
Sorafenib (BAY 43-9006), Bayer |
| Principal Investigator/s; Institution/s: |
Jorge Cortes, MD, M.D. Anderson Cancer Center |
| FLT3 Variation Required for Study Enrollment? |
No |
|
