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Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers

NCT01497392 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-07-22

No results posted yet for this 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

Conditions

  • Adenocarcinoma of the Pancreas
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

dovitinib lactate

Given PO

DRUG

gemcitabine hydrochloride

Given IV

DRUG

capecitabine

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

enzyme-linked immunosorbent assay

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Renuka Iyer · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-29
Primary Completion
2015-08-31
Completion
2017-02-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497392 on ClinicalTrials.gov