Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial
Official title:
MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients With Tumors With DDR2 Mutations
NCT number | NCT04439305 |
Other study ID # | NCI-2020-03342 |
Secondary ID | NCI-2020-03342EA |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | February 25, 2016 |
Verified date | June 2020 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II MATCH treatment trial identifies the effects of dasatinib in patients whose cancer has a genetic change called DDR2 mutation. Dasatinib may block proteins called tyrosine kinases, which may be needed for cancer cell growth. Researchers hope to learn if dasatinib will shrink this type of cancer or stop its growth.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | June 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol - Patients must have one of the following missense mutations in DDR2: S768R, I638F, L239R - Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block) - Patients with known left ventricular dysfunction must have an echocardiogram (ECHO) or a nuclear study (multigated acquisition scan [MUGA] or First Pass) within 4 weeks prior to registration to treatment and must not have left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible Exclusion Criteria: - Patients must not have known hypersensitivity to dasatinib or compounds of similar chemical or biologic composition - Patients with prior use of dasatinib will be excluded - Dasatinib should NOT be given in the presence of STRONG CYP 3A4 inhibitors/inducers. Patients who take these drugs concurrently are ineligible for treatment with dasatinib. These drugs must be discontinued prior to initiation of dasatinib - Dasatinib should NOT be given in the presence of H2-antagonists or proton pump inhibitors. Patients who take these drugs concurrently are ineligible for treatment with dasatinib. These drugs must be discontinued prior to initiation of dasatinib. Antacids taken 2 hours before or after dasatinib administration can be used in place of H2-antagonists or proton pump inhibitors if some acid-reducing therapy is needed |
Country | Name | City | State |
---|---|---|---|
United States | ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) | ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR. | Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration | |
Secondary | Overall survival (OS) | OS is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date. OS will be evaluated specifically for each drug (or step) using the Kaplan-Meier method. | Assessed every 3 months for =< 2 years and every 6 months for year 3 | |
Secondary | Progression free survival (PFS) | Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method. | Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT05106374 -
Risk of Chemotherapy Toxicity in Older Patients With Blood Cancer or Non-small Cell Lung Cancer
|
||
Recruiting |
NCT05660421 -
Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
|
Phase 2 | |
Suspended |
NCT04060849 -
Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
|
Phase 1 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Withdrawn |
NCT04127721 -
Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation
|
Phase 2 | |
Active, not recruiting |
NCT03712878 -
2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies
|
Phase 2 | |
Active, not recruiting |
NCT06062901 -
An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors
|
N/A | |
Terminated |
NCT04081298 -
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors
|
N/A | |
Completed |
NCT04983901 -
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
|
Phase 2 | |
Recruiting |
NCT04188912 -
Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study
|
||
Active, not recruiting |
NCT04592250 -
Financial Toxicity in Cancer Patients
|
||
Recruiting |
NCT05112614 -
Role of Gut Microbiome in Cancer Therapy
|
||
Active, not recruiting |
NCT04296305 -
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
|
Phase 4 | |
Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
Terminated |
NCT04083170 -
Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers
|
Phase 2 | |
Recruiting |
NCT02464696 -
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
|
N/A | |
Withdrawn |
NCT04820894 -
Perception of Cure Among Patients With Metastatic Cancer
|
||
Completed |
NCT03125070 -
Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant
|
Phase 3 | |
Completed |
NCT01664910 -
CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies
|
Phase 1/Phase 2 |