ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Patients must have histologically confirmed solid malignancy that is metastatic or unresectable or lymphoma, for which standard curative or palliative measures that improve survival by at least three months do not exist or are no longer effective. For the purpose of this study patients with leukemia are not eligible.
2. Age >/= 16 years.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status = 2.
4. Patients must have normal organ and marrow function as followed defined: ANC >/= 1,000/mcL; Plt >/=75,000/mcL; total bilirubin =2.0 mg/dL; AST (TGO)/ALT (TGP) =2.5x upper limit of normal; if liver metastasis are present, then = 5.0x upper limit; estimated creatinine clearance by Cockcroft-Gault equation > 30 mL/min
5. The effects of Dasatinib and Crizotinib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
6. Patients receiving palliative radiation will be eligible after a wash-out period of 2 weeks between finishing radiation and initiation of study drugs. Palliative radiation will not be allowed during cycle 1 of treatment but is permitted in this study during following cycles as long as there are evaluable lesions that are not being irradiated
7. Signed informed consent approved by the Institutional Review Board prior to patient entry.
8. Expanded cohort only: Cohort 1: patients with predominant metastatic bone disease; Cohort 2: patients with primary squamous head and neck cancers; Cohort 3: patients presenting any molecular abnormality of interest, which can include an ALK translocation, ALK amplification, ALK mutation and overexpression as determined by FISH, IHC, qPCR, qRT-PCR, array Comparative Genomic Hybridization or direct sequencing (aCGH); a c-MET abnormality, either c-MET amplification by FISH, overexpression by IHC or c-MET mutation; BRAF, DDR2 and CDKN2A mutations; and, finally, TRIM 16 expression and CCN2 expression.
1. Patient receiving any concurrent chemotherapy.
2. Concurrent severe and/or uncontrolled medical disease including, but not limited to,
ongoing or active infection requiring intravenous antibiotics.
3. Symptomatic congestive heart failure (NYHA Class III or IV), or unstable angina
pectoris.
4. Presence of symptomatic pleural and/or pericardial effusion not appropriated treated.
5. Prolonged QTc interval (>/=500 msec), as calculated by Bazett's formula.
6. Psychiatric problems of sufficient severity to limit full compliance with the study or
expose patients to undue risk.
7. Known anaphylactic or severe hypersensitivity to Dasatinib or Crizotinib or their
analogs.
8. Patient has failed to recover from any prior surgery within 4 weeks of study entry.
9. Patient is pregnant or lactating. Pregnant women are excluded from this study because
dasatinib and crizotinib are agents with the potential for teratogenic or
abortifacient effects (Pregnancy category D).
10. Patient has had any treatment specific for tumor control within 3 weeks of dosing with
investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given
weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of
biological targeted agents.
11. Patient is not able to swallow oral medication.
12. Patients receiving any medications or substances that are strong inhibitors or
inducers of CYP3A4 complex are ineligible.
13. Patients with known pulmonary hypertension.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Houston, Texas
- Milwaukee, Wisconsin
- Milwaukee, Wisconsin
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Newport Beach, California
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- Aurora, Colorado
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Syracuse, New York
- San Antonio, Texas
- San Antonio, Texas
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Dasatinib and Crizotinib in Advanced Cancer | ||||
Official Title ICMJE | A Phase I Trial of Dasatinib in Combination With Crizotinib in Patients With Advanced Malignancies | ||||
Brief Summary | 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. This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Crizotinib is FDA approved and commercially available for the treatment of lung cancer. The combination of dasatinib and crizotinib is currently being used for research purposes only. Up to 176 participants will take part in this study. All will be enrolled at MD Anderson | ||||
Detailed Description | Study Groups: Dose Escalation Group: If you are found to be eligible to take part in this study, you will be assigned to a either Arm A or Arm B based when you joined this study, the disease type, and the drugs you have taken in the past. Up to 5 dose levels of the study drug will be tested in each arm. Up to 6 participants will be enrolled in each dose level of arms A and B. The first group of participants in Arm A will receive the FDA approved dose of crizotinib plus the lowest dose level of dasatinib. The first group of participants in Arm B will receive the FDA approved dose of dasatinib plus the lowest dose level of crizotinib. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found. The dose level of the study drug combination that you receive may be lowered if you have intolerable side effects. Dose Expansion Group: After the highest tolerable dose level of the study drug combination for each arm is found, up to 10 additional participants will be enrolled in the dose expansion group and will receive the highest dose of the study drug combination that was tolerated in the dose escalation group. Study Drug Administration: Each study cycle is 28 days. All participants will take dasatinib by mouth 1 time each day. You will take this drug alone on Day 1 of Cycle 1, before the first day you receive the study drug combination. Then starting on Day 2 of Cycle 1, you will begin taking crizotinib by mouth 1 time daily, 1 time every other day, or 2 times daily depending on the dose level of the study drug you are assigned to. You should take dasatinib and crizotinib at least 1 hour before meals. Study Visits: You will have study visits on Days 1 and 15 of Cycle 1, and again before you begin each new cycle (once every 28 days). At each study visit, you will be asked about any drugs you may be taking and any side effects you may be having. Blood/Tumor Samples and Imaging Scans If you are in the dose expansion group:
All study participants:
During Week 4 of Cycle 2 and then every 2-3 cycles:
Length of Study: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if intolerable side effects occur or if you are unable to follow study directions. If the disease gets worse, you may be eligible to continue taking the study drug. The study doctor will discuss this with you. Your participation on the study will be over after you have completed the end-of-study visit. End-of-Study Visit: Within 30 days after your last dose of study drugs, you will have an end-of-study visit and the following tests and procedures performed:
| ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Advanced Cancers | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 62 | ||||
Original Estimated Enrollment ICMJE | 176 | ||||
Actual Study Completion Date ICMJE | March 2019 | ||||
Actual Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01744652 | ||||
Other Study ID Numbers ICMJE | 2012-0721 NCI-2013-00071 ( Registry Identifier: NCI CTRP ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
| ||||
PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |