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NCT01497392 · ClinicalTrials.gov registry record · Phase 1
Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers
A Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Stage IV Pancreatic Cancer, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01497392: Completed Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Stage IV Pancreatic Cancer, sponsored by Roswell Park Cancer Institute.
NCT01497392 is a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Stage IV Pancreatic Cancer that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 26 participants, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497392, a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Stage IV Pancreatic Cancer, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is studying the side effects and best dose of dovitinib lactate when given together with gemcitabine hydrochloride and capecitabine in treating patients with advanced or metastatic solid tumors or advanced pancreatic cancer. Dovitinib lactate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving dovitinib lactate together with combination chemotherapy may kill more tumor cells
Primary Outcome
All toxicities and adverse events will be summarized with frequencies and descriptive measures, and tabulated according to body system, severity and relation to treatment.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG capecitabine
- DRUG gemcitabine hydrochloride
- OTHER enzyme-linked immunosorbent assay
- DRUG dovitinib lactate
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2012-03-29 |
| Est. Completion | 2017-02-07 |
| Phase | Phase 1 |
What the finished NCT01497392 record still lists
NCT01497392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01497392 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01497392 about?
NCT01497392 is a clinical study titled "Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers". This phase I trial is studying the side effects and best dose of dovitinib lactate when given together with gemcitabine hydrochloride and capecitabine in treating patients with advanced or metastatic solid tumors or advanced pancreatic cancer. Dovitinib lactate may stop the growth of tumor cells by ...
What is the current status of trial NCT01497392?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2012-03-29. Estimated completion is 2017-02-07.
What conditions does trial NCT01497392 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Stage IV Pancreatic Cancer, Stage III Pancreatic Cancer, Adenocarcinoma of the Pancreas.
What interventions are being tested in trial NCT01497392?
The interventions under investigation include: laboratory biomarker analysis (OTHER), capecitabine (DRUG), gemcitabine hydrochloride (DRUG), enzyme-linked immunosorbent assay (OTHER), dovitinib lactate (DRUG).
Who is sponsoring clinical trial NCT01497392?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01497392 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unspecified Adult Solid Tumor, Protocol Specific
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01497392's enrollment target sits among peer trials
26 62nd of 83 higher than 21 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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