{
"info": {
"nct_id": "NCT01888965",
"official_title": "A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers",
"inclusion_criteria": "* Patients with a confirmed diagnosis of:\n\n 1. Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance \"standard of care\", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade 1.\n 2. Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less.\n* Prior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment.\n* No concomitant anti-cancer treatment is allowed\n* Age >/= 18 years\n* Performance status of 0-1\n* Adequate hepatic, bone marrow, and renal function\n* Partial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.5.\n* Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts\n* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating.\n* Subject is capable of understanding and complying with protocol demands and able to sign and date the informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant.\n* Women who are breast-feeding\n* Fertile males unwilling to use contraception\n* Patients with brain metastases or any history of brain metastases\n* Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from such therapy\n* Patients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib\n* The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.\n* Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\n* Patients who are currently receiving prasugrel\n* No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate\n* No concurrent use of other investigational drugs or antineoplastic therapies.\n* Patients with impaired cardiac function or clinically significant cardiac diseases.",
"miscellaneous_criteria": ""
},
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