NCT01497392

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

Completed Phase 1 Last updated 22 July 2022

What this trial tests

Phase 1 trial testing dovitinib lactate in Adenocarcinoma of the Pancreas in 26 participants. Completed in 7 February 2017.

Timeline

29 March 2012

Primary endpoint
31 August 2015

7 February 2017

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	29 March 2012
Primary completion	31 August 2015
Estimated completion	7 February 2017
Sites	1 location across United States

Drugs / interventions tested

• dovitinib lactate
• gemcitabine hydrochloride — full drug profile →
• capecitabine (capecitabine) — full drug profile →
• laboratory biomarker analysis — full drug profile →
• enzyme-linked immunosorbent assay
• pharmacological study — full drug profile →

Conditions studied

• Adenocarcinoma of the Pancreas — all drugs for Adenocarcinoma of the Pancreas →
• Stage III Pancreatic Cancer — all drugs for Stage III Pancreatic Cancer →
• Stage IV Pancreatic Cancer — all drugs for Stage IV Pancreatic Cancer →
• Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Adenocarcinoma of the Pancreas or Stage III Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the tumour microenvironment in ovarian cancer.
   Hansen JM, Coleman RL, Sood AK. · · 2016 · cited 92× · PMID 26849037 · DOI 10.1016/j.ejca.2015.12.016
2. Cholangiocarcinoma: molecular pathways and therapeutic opportunities.
   Ilyas SI, Borad MJ, Patel T, Gores GJ. · · 2014 · cited 92× · PMID 25369307 · DOI 10.1055/s-0034-1394144
3. Combating pancreatic cancer with PI3K pathway inhibitors in the era of personalised medicine.
   Conway JR, Herrmann D, Evans TJ, Morton JP, et al · · 2019 · cited 75× · PMID 30396902 · DOI 10.1136/gutjnl-2018-316822
4. Cancer of the Pancreas: Molecular Pathways and Current Advancement in Treatment.
   Polireddy K, Chen Q. · · 2016 · cited 68× · PMID 27471566 · DOI 10.7150/jca.14922
5. Current therapeutic strategies for advanced pancreatic cancer: A review for clinicians.
   Spadi R, Brusa F, Ponzetti A, Chiappino I, et al · · 2016 · cited 64× · PMID 26862489 · DOI 10.5306/wjco.v7.i1.27
6. Genomics of gallbladder cancer: the case for biomarker-driven clinical trial design.
   Sicklick JK, Fanta PT, Shimabukuro K, Kurzrock R. · · 2016 · cited 41× · PMID 26857926 · DOI 10.1007/s10555-016-9602-8
7. Enhanced FGFR signalling predisposes pancreatic cancer to the effect of a potent FGFR inhibitor in preclinical models.
   Zhang H, Hylander BL, LeVea C, Repasky EA, et al · · 2014 · cited 37× · PMID 24327018 · DOI 10.1038/bjc.2013.754
8. Promising Molecular Targets for the Targeted Therapy of Biliary Tract Cancers: An Overview.
   Yang W, Sun Y. · · 2021 · cited 17× · PMID 33658799 · DOI 10.2147/ott.s297643