NEWS HIGHLIGHTSMedia Articles Related to Sprycel (Dasatinib)
Cytosine Methylation Likely Plays A Key Role In Fueling Pediatric Acute Lymphoblastic Leukemia
Source: Genetics News From Medical News Today [2013.06.12]
Changes in an epigenetic mechanism that turns expression of genes on and off may be as important as genetic alterations in causing pediatric acute lymphoblastic leukemia (ALL), according to a study led by scientists at St. Jude Children's Research Hospital and published online in the Journal of Clinical Investigation...
Chronic Myeloid Leukemia Patients On Kinase Inhibitors Report Serious Quality-Of-Life Issues
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.06.12]
Researchers at Moffitt Cancer Center have determined that chronic myeloid leukemia patients who are treated with a class of oral chemotherapy drugs known as a tyrosine kinase inhibitors have significant side effects and quality-of-life issues that need to be addressed. Some of these issues include depression, fatigue, nausea and change of appearance...
Normal Version Of Molecular Pathway Affected In Poor-Prognosis Childhood Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.06.11]
Through genetic engineering of laboratory models, researchers at Dartmouth-Hitchcock Norris Cotton Cancer Center have uncovered a vulnerability in the way cancer cells diverge from normal regenerating cells that may help treat children with leukemia as reported in the journal PNAS...
Never-Before-Used Targeted Treatment For Atypical Chronic Neutrophilic Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.06.07]
A recent article in the New England Journal of Medicine describes genetic testing of a rare blood cancer called atypical chronic neutrophilic leukemia (CNL) that revealed a new mutation present in most patients with the disease. The mutation also serves as an Achilles heel, allowing doctors at the University of Colorado Cancer Center to prescribe a never-before-used, targeted treatment...
New Drug Target Identified In Deadly Form Of Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.06.05]
A research team led by the Duke-NUS Graduate Medical School (Duke-NUS) in Singapore has identified ways to inhibit the function of a key protein linked to stem cell-like behavior in terminal-stage chronic myeloid leukemia (CML), making it possible to develop drugs that may extend the survival of these patients...
Published Studies Related to Sprycel (Dasatinib)
Comparative efficacy of nilotinib and dasatinib in newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison of randomized trials. [2011.06]
OBJECTIVE: Nilotinib and dasatinib have not been directly compared in a randomized trial for the treatment of newly diagnosed chronic myeloid leukemia in the chronic phase (CML-CP). The purpose of this study was to indirectly compare rates of major molecular response (MMR), progression-free survival (PFS) and overall survival by month 12 with nilotinib and dasatinib treatment of newly diagnosed CML-CP... CONCLUSION: Nilotinib was associated with significantly higher rates of MMR and overall survival compared with dasatinib by month 12 in the treatment of newly diagnosed CML-CP.
Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. [2010.06.17]
BACKGROUND: Treatment with dasatinib, a highly potent BCR-ABL kinase inhibitor, has resulted in high rates of complete cytogenetic response and progression-free survival among patients with chronic myeloid leukemia (CML) in the chronic phase, after failure of imatinib treatment. We assessed the efficacy and safety of dasatinib, as compared with imatinib, for the first-line treatment of chronic-phase CML... CONCLUSIONS: Dasatinib, administered once daily, as compared with imatinib, administered once daily, induced significantly higher and faster rates of complete cytogenetic response and major molecular response. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML. (ClinicalTrials.gov number, NCT00481247.) 2010 Massachusetts Medical Society
Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. [2010.03]
Dasatinib 70 mg twice daily is indicated for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) intolerant or resistant to imatinib. In patients with chronic-phase chronic myelogenous leukemia, once-daily dosing has similar efficacy with improved safety, compared with twice-daily dosing...
Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib. [2010.02]
BACKGROUND: Dasatinib 100 mg once daily achieves intermittent BCR-ABL kinase inhibition and is approved for chronic-phase chronic myeloid leukemia patients resistant or intolerant to imatinib. To better assess durability of response to and tolerability of dasatinib, data from a 2-year minimum follow-up for a dose-optimization study in chronic-phase chronic myeloid leukemia are reported here... CONCLUSIONS: Intermittent kinase inhibition can achieve rapid and durable responses, indistinguishable from those achieved with more continuous inhibition.
Phase III, randomized, open-label study of daily imatinib mesylate 400 mg versus 800 mg in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase using molecular end points: tyrosine kinase inhibitor optimization and selectivity study. [2010.01.20]
PURPOSE: To evaluate the safety and efficacy of initial treatment with imatinib mesylate 800 mg/d (400 mg twice daily) versus 400 mg/d in patients with newly diagnosed chronic myeloid leukemia in chronic phase... CONCLUSION: MMR rates at 1 year were similar with imatinib 800 mg/d and 400 mg/d, but MMR and CCyR occurred earlier in patients treated with 800 mg/d. Continued follow-up is needed to determine the clinical significance of earlier responses on high-dose imatinib.
Clinical Trials Related to Sprycel (Dasatinib)
Efficacy and Safety Study of Dasatinib in Patients With Chronic Myeloid Leukemia [Recruiting]
This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic
effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia
(CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other
treatment, such as imatinib therapy.
A relapse is when an illness that has seemed to be getting better, or to have been cured,
comes back or gets worse again.
A total of 50 patients ≥18 years of age will be registered on the trial.
Ph I Dasatinib + Erlotinib in Recurrent MG [Recruiting]
Primary:
To determine maximum tolerated dose & dose limiting toxicity of dasatinib when combined w
erlotinib among pts w recurrent MG
Secondary:
To further evaluate safety & tolerability of dasatinib + erlotinib To evaluate
pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are
on & not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity
with this regimen in this patient population
Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma [Recruiting]
Phase I:
Primary Objectives:
- To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT)
and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m^2/day in patients with
newly-diagnosed glioblastoma (GBM).
Secondary Objectives:
- To characterize the safety profile of dasatinib (Sprycel) in combination with
radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM.
- To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant
TMZ in patients with glioblastoma after RT.
Phase II:
Primary Objectives:
- To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of
concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant
temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM)
as measured by overall survival.
Secondary Objectives:
- To determine the efficacy of this treatment as measured by radiographic response (RR),
progression-free survival (PFS) and time to progression (TTP).
- To characterize the safety profile of dasatinib (Sprycel) in combination with RT and
concomitant TMZ in patients with newly-diagnosed GBM.
- To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant
TMZ in patients with GBM after RT.
Exploratory Objectives:
- To correlate tumor genotype, tumor expression of dasatinib target proteins (e. g. Src,
EphA2, c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and
temozolomide.
XAD - Xelox (Capecitabine + Oxaliplatin) + Bevacizumab + Dasatinib [Recruiting]
The primary purpose of this study is to find the highest tolerated dose of the study drugs:
capecitabine, oxaliplatin, bevacizumab, and dasatinib given in combination to subjects with
advanced solid tumors. This will occur in the first part of the study (Phase I). Once this
dose has been determined, it will be given to subjects with advanced metastatic colorectal
cancer in the second part of the study (Phase II).
By giving these drugs in combination, researchers hope to evaluate the side effects of the
study drugs in both groups, and to determine if this combination could possibly decrease or
stabilize the cancer being treated.
Subjects will be enrolled at Duke University Medical Center (DUMC) and Rocky Mountain
Cancer Center.
After satisfying eligibility and screening criteria, patients will be treated on 21 day
cycles.
ABOUT THE STUDY DRUGS
- Capecitabine (Xeloda™) is an oral (taken by mouth) chemotherapy drug in tablet form
made by Roche Laboratories Inc. Capecitabine has been approved for use by the Food and
Drug Administration (FDA) for first line treatment (treatment that should be used for
cancer that has not been treated yet) of metastatic colorectal cancer and also for
metastatic breast cancer.
- Oxaliplatin (Eloxatin™) is an intravenous (given by injection into a vein) chemotherapy
drug made by Sanofi-Synthélabo. This drug is also approved by the FDA for use in
metastatic colorectal cancer.
- Bevacizumab (Avastin™) is a type of intravenous cancer treatment called anti-angiogenic
therapy (a type of therapy to treat cancer that interferes with blood flow to the
tumor, thereby stopping tumor growth, and possibly leading to tumor shrinkage) made by
Genentech Inc. Bevacizumab is approved by the FDA for first line treatment of
metastatic colorectal cancer in combination with other chemotherapy.
- Dasatinib (Sprycel™) is an oral drug made by BMS, Inc. Dasatinib is approved by the
FDA for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia
or for patients that are resistant to a medicine called imatinib mesylate (Gleevec™ ).
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923) [Recruiting]
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP)
CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
Reports of Suspected Sprycel (Dasatinib) Side Effects
Pleural Effusion (175),
Headache (78),
Death (77),
Nausea (74),
Diarrhoea (74),
Neoplasm Malignant (71),
Fatigue (64),
Dyspnoea (51),
Rash (51),
Anaemia (47), more >>
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