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Gastric CancerPhase 2NCT01719549

Dovitinib for Gastric Cancer With FGFR2 Amplification: GASDOVI-1

A Phase 2 study testing Dovitinib in people with Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, prospective, single-arm, open-label phase II study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Dovitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSouth Korea
Study dates
Sep 2012to Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven metastatic or unresectable adenocarcinoma of stomach or gastroesophageal junction
  • Patients with progressive disease (radiological confirmation required) after one or two lines of chemotherapy in palliative setting for advanced gastric cancer. Adjuvant or neoadjuvant chemotherapy is not counted as one line of prior chemotherapy.
  • FGFR2 amplification (copy number > 3, identified by real time PCR using TaqMan probe) by prescreening or screening procedure. Prescreening can be performed with Real Time PCR for FGFR2 amplification any time during the prior chemotherapy. At least 18 patients should have 6 or more copy numbers of FGFR2 (see Statistical Methods and Data Analysis).
  • Presence of at least one measurable disease (for co-primary endpoint of overall response rate in patients with FGFR2 copy number > 6) or one evaluable disease (for co-primary endpoint of PFS in patients with FGFR2 copy number > 3) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Age of 18 years or older
  • Expected life expectancy of more than 3 months
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  • ECOG performance status 0~2
  • Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 4.0
  • Adequate bone marrow, hepatic, renal, and other organ functions ( Neutrophil > 1,500/mm3, Platelet > 75,000/mm3, Hemoglobin > 8.0 g/dL, Total bilirubin < 1.5 x upper limit of normal (ULN), AST/ALT < 2.5 x ULN (or < 5 x ULM in case of liver metastases), Creatinine < 1.5 x ULN, Amylase, lipase < ULN, Electrolytes should be within normal limits.,Urine dipstick reading: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein 500 mg and measured creatinine clearance 50 mL/min/1.73m2 from a 24-hour urine collection)
  • Women with reproductive potential must have a negative serum or urine pregnancy test; and men and women of reproductive potential must practice an effective method of avoiding pregnancy while receiving study drug.
  • Washout period of previous chemotherapy for more than 4 times the half life or at least 2 weeks after completion of prior chemotherapy whichever comes first
  • No prior FGF/FGFR inhibitor
  • No prior radiation therapy within 2 weeks of the study (Irradiated lesions should not be included in the evaluable lesions.)
  • Written informed consent

Who cannot join

  • 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
  • Bowel obstruction
  • Evidence of serious gastrointestinal bleeding
  • Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test 72 hours prior to starting TKI258.
  • Clinically significant cardiac disease (New York Heart Association, Class III or IV) or impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
  • (LVEF < 45% as determined by MUGA scan or echocardiogram, Complete left bundle branch block, Obligate use of a cardiac pacemaker, Congenital long QT syndrome, History or presence of ventricular tachyarrhythmia, Presence of unstable atrial fibrillation (ventricular response > 100 bpm). Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria, Clinically significant resting bradycardia (< 50 bpm), Uncontrolled hypertension (systolic blood pressure 150 mmHg and/or diastolic blood pressure 100 mmHg, with or without anti-hypertensive medication)., QTc > 480 msec on screening ECG, Right bundle branch block + left anterior hemiblock (Bifascicular block), Angina pectoris 3 months prior to starting study drug, Acute Myocardial Infarction 3 months prior to starting study drug, Other clinically significant heart disease (e.g., Congestive heart failure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen))
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  • Uncontrolled infection
  • Diabetes mellitus (insulin dependent or independent disease, requiring chronic medication) with signs of clinically significant peripheral vascular disease.
  • Previous pericarditis; clinically significant pleural effusion in the previous 12 months or current ascites requiring two or more interventions/month.
  • Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis,adrenal or thyroid glands.
  • Prior acute or chronic pancreatitis of any etiology.
  • Acute and chronic liver disease and all chronic liver impairment.
  • Malabsorption syndrome or uncontrolled gastrointestinal toxicities (nausea, diarrhea,vomiting) with toxicity greater than NCI CTCAE grade 2.
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study.
  • Treatment with any of the medications that have a potential risk of prolonging the QT interval or inducing Torsades de Points and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
  • Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, rifampin, phenytoin and quinidine 2 weeks prior baseline.
  • Major surgery 28 days prior to starting study drug or who have not recovered from side effects of such therapy.
  • Known diagnosis of HIV infection (HIV testing is not mandatory).
  • Patients with brain metastases as assessed by radiologic imaging (e.g. CT, MRI)
  • Alcohol or substance abuse disorder

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase II Trial of Dovitinib Monotherapy as Salvage Treatment in Patients With Metastatic or Unresectable Gastric Cancer Harboring FGFR2(Fibroblast Growth Factor Receptor 2) Amplification After Failure of First or Second Line Chemotherapy

This is a single-center, prospective, single-arm, open-label phase II study

Read the detailed description

In this study, we will evaluate the efficacy and safety of TKI258(Dovitinib) monotherapy as a salvage chemotherapy after failure of standard first or second-line chemotherapy in metastatic or unresectable gastric cancer harboring FGFR2 amplification.

Conditions
Gastric Cancer
Being tested
Dovitinib
Keywords
Gastric Cancer, Dovitinib
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DovitinibDrug

    Also called TKI258

    • Study treatment: TKI258 single agent on a 5 days-on/2 days-off schedule
    • Study drug: TKI258 capsule
    • Dose: 500mg p.o. qd
    • Every 3 weeks
Study groups in NCT01719549
Study groupRoleWhat they receive
DovitinibExperimentalNot described
Receives: Drug: Dovitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. response rate

    To evaluate with abdominal and pelvic dynamic CT scan every 6 weeks using RECIST version 1.1

    Measured: 1year

  2. Progression-free survival

    To evaluate progression-free survival (PFS) with TKI258(Dovitinib) administered orally at 500 mg/day on a 5 days on/2 days off dosing schedule to adult patients > 18 years with evaluable metastatic or unresectable gastric cancer harboring FGFR2 amplification (copy number > 3, identified by real time PCR using TaqMan probe) who failed one or two lines of chemotherapy in palliative setting.

    Measured: From date of enrollment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary outcomes (3)

  1. Number of Adverse Events

    Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.

    Measured: 1year

  2. Evaluation of Efficacy

    To correlate concentrations of circulating growth factors, soluble receptors with efficacy (response rate, progression free survival, and overall survival) of TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule.

    Measured: From date of randomization to death from any cause, assessed up to 2 years

  3. FGFR2 copy number

    To compare FGFR2 copy number determined by FISH(fluorescence in situ hybridization) with FGFR2 copy number identified by real time PCR using TaqMan Probe.

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionFeb 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719549
Sponsor's protocol ID
AMC1202
Status last verified
Jan 2020
First submitted
22 Oct 2012
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dovitinib in people with Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response rate (time frame: 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01719549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

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