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Dovitinib Plus Docetaxel in Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01921673
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Dovitinib and docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Trial of Dovitinib Plus Docetaxel as Second-line Chemotherapy in Patients With Metastatic or Unresectable Gastric Cancer After Failure of First-line Chemotherapy
Actual Study Start Date : August 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Dovitinib plus docetaxel

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

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.





Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 6 months ]
    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.

  2. Progression-free survival [ Time Frame: 2 year ]
    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.


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 2 year ]
    Proportion of patients with complete and partial response according to the Response Evaluation Criteria in Solid Tumors version 1.1

  2. Toxicity [ Time Frame: 2 years ]
    Adverse events caused by study drugs according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  3. Overall survival [ Time Frame: 2 years ]
    Time from start of study treatment to any cause of death

  4. Biomarker [ Time Frame: Baseline and 2 weeks after study treatment ]
    FGFR2 copy number will be evaluated in blood and tumor tissue. Treatment efficacy including overall response rate, progression-free survival, and overall survival will be compared according to FGFR2 copy number determined by both FISH and real time PCR using TaqMan probe.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
  3. Bowel obstruction
  4. Evidence of serious gastrointestinal bleeding
  5. Presence of central nervous system (CNS) metastasis
  6. History of significant neurologic or psychiatric disorders
  7. Significant cardiac disease within 6 months of the study (congestive heart failure uncontrollable by medication, symptomatic coronary heart disease, or arrhythmia, myocardial infarction)
  8. Left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA), < 45%
  9. 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.
  10. QTc > 480 msec on screening ECG
  11. 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
  12. History of thrombotic or bleeding diathesis or coagulopathy
  13. Serious non-healing wound, peptic ulcer, or bone fracture
  14. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
  15. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  16. Other serious illness or medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921673


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Yoon-Koo Kang, M.D., Ph.D. Asan Medical Center

Publications:
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Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01921673     History of Changes
Other Study ID Numbers: AMC1302
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Gastric cancer
Phase I/II
Second-line chemotherapy
Dovitinib
Docetaxel
Refractory to first-line chemotherapy

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action