Clinical trialPhase 2Terminated
Maintenance Dovitinib for Colorectal and Pancreas Cancer
A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers
- Outcome
- Stopped earlyAdverse Event issues. (Toxicity)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- October 2013
- Expected end
- October 2014
- Enrollment
- 9 participants
- Sites
- 1
- Primary outcomes
- Biomarker Discovery
- Sponsor
- Other
- Results posted
- 2016-07-19
- Last update
- 19 July 2016
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Brief summary public domain (ClinicalTrials.gov)
This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had surgery to remove metastases and patients with pancreas cancer, which has been surgically removed and are receiving adjuvant chemotherapy or is locally advanced and have already received chemotherapy and radiation. The purpose of this study is to determine the effects of oral dovitinib in patients with advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to 2 years.
Detailed description public domain (ClinicalTrials.gov)
This is a single institution, nonrandomized, open-label pilot study of dovitinib as maintenance and adjuvant therapy in patients with colorectal and pancreas cancers. Patient Populations: Cohort 1: Stage 4 Colon Cancer s/p metastasectomy (Adjuvant cohort) Cohort 2: Stage 4 Colon Cancer after initial chemotherapy (Maintenance cohort) Cohort 3: Pancreas Cancer s/p resection and adjuvant chemo (Adjuvant cohort) Cohort 4: Locally advanced pancreas cancer s/p chemo and radiation (Maintenance cohort) Each of the 4 cohorts will be accrued independently. 15 patients will be accrued to each cohort. Treatment will begin following the completion of the standard adjuvant or induction therapy. Patients will continue to take dovitinib until they demonstrate progression of disease using standard RECIST criteria, withdraw consent, or experience unacceptable toxicity. Blood and urine Biomarker studies will be performed on all patients in all cohorts. Samples will be collected at baseline and every 8 weeks for the first 6 months and then every 3 months thereafter, while patients are on study. Blood and urine will be collected and banked for protein, miRNA and metabolomic analysis. Tumor specimens will be taken from patients in maintenance cohorts before and 2 weeks after initiation of dovitinib. All of these samples will be analyzed to determine if biomarkers of benefit and progression can be determined.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Biomarker Discovery [2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [2 years]. Median, days (Full Range). Dovitinib (n=9): 46 (13 to 287).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Safety [2 years]. Number, percentage of participants. Dovitinib (n=9): 56.