Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Herbert Hurwitz, MD
With
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Criteria Specific for Dose Escalation (Phase I)
1. Patients must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom capecitabine, oxaliplatin, and/or bevacizumab would be considered a standard therapy or therapeutic option.
2. Patients must not have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within the 28 days prior to study day 1.
Criteria Specific for Expanded Cohort Portion of Trial Only
1. Histologically documented adenocarcinoma of the colon or rectum that is metastatic/recurrent disease
2. No prior chemotherapy for metastatic/recurrent colorectal cancer. Patients may have received a radiosensitizing dose of 5-fluorouracil or capecitabine for the treatment of local disease in the localized or metastatic setting.
3. No history of other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer
4. Disease must be measurable by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
1. Age \>18 years.
2. Karnofsky performance status \> 70%.
3. Life expectancy of at least 3 months.
4. Patients must have adequate organ and marrow function as defined below:
5. Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.
6. All women of child bearing potential (WOCBP) MUST have a negative pregnancy test within 7 days prior to first receiving investigational product.
7. Ability to understand and the willingness to sign a written informed consent document.
You may not be if
1. Patients who have had radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for cancer within the 28 days prior to day 1 of the study (ie - first day of study drug treatment).
2. Patients who have received any other investigational agents within the 28 days prior to day 1 of study drug treatment.
3. Patients with known central nervous system (CNS) metastases.
7. Evidence of bleeding diathesis or coagulopathy. Patients on full-dose anticoagulation are permitted to enroll provided that they have been clinically stable on anti- coagulation.
8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study drug treatment
9. Core biopsy or other minor surgical procedure excluding placement of a vascular access device, within 7 days prior to expected start of treatment.
10. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study day 1
11. Serious, non-healing wound, ulcer, or bone fracture
12. Proteinuria at screening
13. Any prior history of hypertensive crisis or hypertensive encephalopathy
14. New York Heart Association (NYHA) Grade II or greater congestive heart failure
15. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to study treatment day 1
16. History of stroke or transient ischemic attack within 6 months prior to study treatment day 1
17. History of intolerance or hypersensitivity to prior treatment with capecitabine, oxaliplatin, bevacizumab and/or dasatinib.
18. No previous treatment with dasatinib.
19. Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency.
20. Patient with grade 2 or greater peripheral neuropathy
21. Chronic treatment with systemic steroids or another immunosuppressive agent.
22. Other concurrent severe and/or poorly controlled medical condition that could compromise safety of treatment as so judged by treating physician.
23. A known history of HIV seropositivity,hepatitis C virus, acute or chronic active hepatitis B infection, or other serious chronic infection requiring ongoing treatment.
24. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection)
25. Patients unwilling to or unable to comply with the protocol
26. Diagnosed or congenital long QT syndrome
27. Any history of clinically significant ventricular arrhythmias
