XALKORI SUMMARY
XALKORI (crizotinib) is an oral receptor tyrosine kinase inhibitor.
XALKORI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
This indication is based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with XALKORI.
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NEWS HIGHLIGHTS
Clinical Trials Related to Xalkori (Crizotinib)
Dasatinib and Crizotinib in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the
combination of dasatinib and crizotinib that can be given to patients with advanced cancer.
The safety of this drug combination will also be studied.
Dasatinib is designed to block certain proteins from causing cancer cells to grow out of
control. This may cause the cancer cells to die.
Crizotinib is designed to block certain abnormal genes found in cancer cells. This may
cause the cancer cells to die.
Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the
combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed)
or of the combination of 3 study drugs that can be given to patients with advanced cancer.
The safety of these drug combinations will also be studied.
Crizotinib is designed to block a protein called ALK, which is involved in cancer cell
growth and survival.
Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for
tumor growth. This may prevent or slow the growth of cancer cells.
Pemetrexed is designed to block proteins that may cause tumors to grow.
Sorafenib or Crizotinib and Vemurafenib in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the
combination of ZelborafTM (vemurafenib) with NexavarŽ (sorafenib) or XalkoriŽ (crizotinib)
that can be given to patients with advanced cancer. The safety of these drugs will also be
studied.
Vemurafenib is designed to block a protein called BRAFV600E inside the cancer cells, which
is involved in cancer cell growth.
Sorafenib is designed to block the function of important proteins in and outside of cancer
cells. These proteins are involved in cancer cells growth and new blood vessel development.
Crizotinib is designed to block certain abnormal genes found in cancer cells. This may
cause the cancer cells to die.
CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer [Recruiting]
Crizotinib is a medication that is taken by mouth. It has shown that it can help slow down
or stop the growth of tumor cells. The marketing name of the drug is "Xalkori". It has been
approved by the FDA (Food and Drug Administration) to treat other types of metastatic
cancer, but the investigators believe it may be helpful to treat breast cancer as well.
Sunitinib is the other medication used in the study. It is also taken by mouth in the form
of a capsule. The marketing name of this drug is "Sutent". It too has been approved by the
FDA to treat other types of cancer, but not for breast cancer.
In this study the investigators will be combining both of these two treatments, but at
different doses.
One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25. 0 mg
once a day.
One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25. 0 mg
once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with
Sunitinib 37. 5 mg once a day.
Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1 [Recruiting]
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy
and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients
with identified activating molecular alterations in the crizotinib target genes. A cohort is
defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET
amplification).
For each cohort a two-stage design will be implemented. In the situation where expected
accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors
will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic
tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that
the target number may not be achievable in a reasonable timeframe; for these cohorts, the
alpha and beta errors will be fixed at 15%. Consequently three different statistical designs
will be a priori considered according to the expected response rate and incidence.
Reports of Suspected Xalkori (Crizotinib) Side Effects
Nausea (121),
Disease Progression (106),
Death (106),
Vomiting (93),
Diarrhoea (75),
Constipation (68),
Lung Neoplasm Malignant (56),
Fatigue (48),
Oedema Peripheral (44),
Visual Impairment (43), more >>
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Page last updated: 2014-06-05
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