NCT01921673

Brief Summary

Docetaxel is currently one of standard second-line therapy in patients with gastric cancer. As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer, dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of patients with gastric cancer. Therefore, we investigated the combination regimen of docetaxel and dovitinib.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2.8 years

First QC Date

August 10, 2013

Last Update Submit

July 13, 2017

Conditions

Gastric Cancer

Keywords

Gastric cancerPhase I/IISecond-line chemotherapyDovitinibDocetaxelRefractory to first-line chemotherapy

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose

    If dose limiting toxicities are experienced in two or more out of six patients in the cohort (more than 33% of patient cohort), that dose will be defined as the maximum tolerated dose.

    6 months

  • Progression-free survival

    Progression-free survival is defined as the time from the first treatment to the onset of progressive disease or to the date of death whichever comes first.

    2 year

Secondary Outcomes (4)

  • Response rate

    2 year

  • Toxicity

    2 years

  • Overall survival

    2 years

  • Biomarker

    Baseline and 2 weeks after study treatment

Study Arms (1)

Dovitinib plus docetaxel

EXPERIMENTAL

In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.

Drug: Dovitinib and docetaxel

Interventions

Dovitinib and docetaxelDRUG

In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.

Dovitinib plus docetaxel

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven metastatic or unresectable adenocarcinoma of stomach or gastroesophageal junction
  • Patients with progressive disease (radiological confirmation required) after one line of chemotherapy except taxane for advanced gastric cancer in palliative setting
  • Presence of at least one evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Age of 18 to 74 years
  • Estimated life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0\~2
  • Adequate bone marrow function (Absolute neutrophil counts ≥ 1,500/uL, hemoglobin ≥ 8.0g/dL, and platelet ≥ 100,000/uL)
  • Adequate renal function (creatinine \< 1.5mg/dL)
  • Adequate hepatic function (total bilirubin \< 1.5 mg/dL, transaminase \< 3 times the upper normal limit \[5 times for patients with liver metastasis\])
  • No prior anti-angiogenic therapy (anti-VEGF or VEGFR tyrosine kinase inhibitor etc) or FGF/FGFR inhibitor
  • No prior radiation therapy within 4 weeks of the study (Irradiated lesions should not be included in the evaluable lesions.)
  • Written informed consent

You may not qualify if:

  • Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
  • Bowel obstruction
  • Evidence of serious gastrointestinal bleeding
  • Presence of central nervous system (CNS) metastasis
  • History of significant neurologic or psychiatric disorders
  • Significant cardiac disease within 6 months of the study (congestive heart failure uncontrollable by medication, symptomatic coronary heart disease, or arrhythmia, myocardial infarction)
  • Left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA), \< 45%
  • Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to study entry.
  • QTc \> 480 msec on screening ECG
  • Proteinuria defined by NCI CTCAE grade \> 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection ( \> 1g/24hrs). Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
  • History of thrombotic or bleeding diathesis or coagulopathy
  • Serious non-healing wound, peptic ulcer, or bone fracture
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (3)

  • Lee JL, Ryu MH, Chang HM, Kim TW, Yook JH, Oh ST, Kim BS, Kim M, Chun YJ, Lee JS, Kang YK. A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy. Cancer Chemother Pharmacol. 2008 Apr;61(4):631-7. doi: 10.1007/s00280-007-0516-6. Epub 2007 May 23.

    PMID: 17520252BACKGROUND

  • Wesche J, Haglund K, Haugsten EM. Fibroblast growth factors and their receptors in cancer. Biochem J. 2011 Jul 15;437(2):199-213. doi: 10.1042/BJ20101603.

    PMID: 21711248BACKGROUND

  • Yamamoto S, Yasui W, Kitadai Y, Yokozaki H, Haruma K, Kajiyama G, Tahara E. Expression of vascular endothelial growth factor in human gastric carcinomas. Pathol Int. 1998 Jul;48(7):499-506. doi: 10.1111/j.1440-1827.1998.tb03940.x.

    PMID: 9701011BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-oneDocetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Yoon-Koo Kang, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

KR(1)