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dovitinib lactate

Phase 1

Adenocarcinoma of the Pancreas | Small molecule | Oncology |Novartis AG|Last Updated: Jul 22, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

dovitinib lactate · 1 trial · 4 indications

Phase 1 1
NCT01497392Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary CancersAdenocarcinoma of the Pancreas
COMPLETED26 Analytics
PHASE1COMPLETED
Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers
Adenocarcinoma of the PancreasUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) is defined as the highest dose level at which less than 33% of patients experience study treatment-related dose limiting toxicities (DLT)
First course, 21 days

All toxicities and adverse events will be summarized with frequencies and descriptive measures, and tabulated according to body system, severity and relation to treatment.

Overall safety profile characterized by type, frequency, severity (according to National Cancer Institute [NCI] CTCAE version 4.0), timing, seriousness and relationship to study treatment
Up to 30 days post-treatment

All toxicities and adverse events will be summarized with frequencies and descriptive measures, and tabulated according to body system, severity and relation to treatment.

Secondary Endpoints

Plasma pharmacokinetic parameters of dovitinib lactate, gemcitabine hydrochloride, capecitabine and their metabolites
Day 1 and 19 of course 1, day 8 of course 2 (Part A); day -14, day 19 of course 1,and day 8 of course 2 (Part B)
Solid tumor/dose-finding cohort: response rate, progression free survival
Up to 1 year
Pancreas cancer cohort: survival, response rate and progression free survival
At 6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (dovitinib lactate, gemcitabine, and capecitabine)EXPERIMENTALPatients receive dovitinib lactate PO on days 1-5, 8-12, and 15-19, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and capecitabine PO twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
dovitinib lactateDRUGGiven PO
gemcitabine hydrochlorideDRUGGiven IV
capecitabineDRUGGiven PO
laboratory biomarker analysisOTHERCorrelative studies
enzyme-linked immunosorbent assayOTHERCorrelative studies
pharmacological studyOTHERCorrelative studies
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Part A: histologically or cytologically confirmed solid tumors that ale advanced or metastatic that the gemcitabine combination is considered standard therapy or a rational option * Part B: histologically or cytologically confirmed adenocarcinoma of the pancreas or the biliary...

Countries:United States
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Frequently asked questions about dovitinib lactate

What is dovitinib lactate used for in adenocarcinoma of the pancreas?

Dovitinib lactate is an investigational small molecule being studied for use in adenocarcinoma of the pancreas, specifically in patients with advanced or metastatic pancreatic cancer. It was evaluated in a Phase 1 clinical trial in combination with gemcitabine hydrochloride and capecitabine for treating patients with advanced or metastatic solid tumors, pancreatic cancer, and biliary cancers.

Who makes dovitinib lactate?

Dovitinib lactate is being developed by Novartis AG, which trades under the ticker symbol NVS. The company sponsored a Phase 1 clinical trial of the drug in combination with other agents for the treatment of pancreatic cancer and other solid tumors.

What phase is dovitinib lactate in?

Dovitinib lactate is in Phase 1 clinical development. It has completed a Phase 1 trial (NCT01497392) that evaluated the drug in combination with gemcitabine hydrochloride and capecitabine in patients with advanced or metastatic solid tumors, including pancreatic cancer. The drug is investigational and not yet approved.

What clinical trials is dovitinib lactate in?

Dovitinib lactate has been studied in one completed clinical trial, NCT01497392. This Phase 1 trial enrolled 26 participants and evaluated dovitinib lactate in combination with gemcitabine hydrochloride and capecitabine for treating patients with advanced or metastatic solid tumors, pancreatic cancer, and biliary cancers. The trial was conducted in the United States.

How does dovitinib lactate work?

Dovitinib lactate is a small molecule that works by inhibiting multiple receptor tyrosine kinases, which are enzymes involved in cell signaling and tumor growth. By blocking these targets, the drug aims to interfere with cancer cell proliferation and survival. This mechanism was evaluated in the context of pancreatic cancer and other solid tumors.