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Unresectable and Advanced CholangiocarcinomaPhase 2SUN-CKNCT01718327

A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma

A Phase 2 study testing Sunitinib in people with Unresectable and Advanced Cholangiocarcinoma, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.

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

For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered as the reference treatment in first line chemotherapy. However, the outcomes of these patients remain limited and therefore more effective drugs are warranted. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
6 sitesFrance
Study dates
1 Sep 2011to 17 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent given according to ICH/GCP, and local regulation.
  • Histologically or cytologically proven intrahepatic cholangiocarcinoma.
  • Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
  • Gemcitabine with or without platinum pre-treated patients with documented progression
  • Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI).
  • Measurable tumor according to RECIST criteria with at least one unidimensionally measurable target lesion
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  • No evidence of biliary duct obstruction unless obstruction controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin £ 1.5xULN.
  • Age between 18 and 80 years old
  • Eastern Cooperative Oncology Group (ECOG) Performance Status :0-1
  • Life expectancy ≥ 3 months.
  • Ability to swallow oral compound.
  • No acute toxic effects of previous treatment superior to grade to 1.
  • Laboratory requirements:
  • Hematologic: absolute neutrophil count (ANC) 1.5 x 103/mm3, platelets 100 x 103/mm3, hemoglobin 9 g/dl and Hepatic: Bilirubin < 1.5 x upper normal limit (ULN), and alkaline phosphatase (AP) 5xULN. AST and ALT may be 5 x ULN Patients with jaundice Prothrombin time and partial thromboplastin time 1.7 xULN, serum albumin 2.8 g/dl. Renal: Serum creatinine 1.5 xULN , and clearance > 60 ml/min.
  • Normal cardiovascular function
  • Adequate organ function
  • No cardiovascular events during the year prior to study entry
  • Female patients must be surgically sterile or postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to starting study drug. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator or a designated associate
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
  • Registration in a national health care system (CMU included).

Who cannot join

  • Hilar cholangiocarcinomas, cholangiocarcinomas located in the gall bladder, hepatic capsule effraction, extrahepatic primary cholangiocarcinoma, carcinoma of the Water ampullum.
  • Prior treatment with other chemotherapy than gemcitabine and/or platinum.
  • Concomitant treatment with any chemotherapy, chemoembolization therapy, immunotherapy, antitumoral hormonotherapy or investigational anticancer agents..
  • Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors.
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
  • Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration.
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  • Pre-existing thyroid abnormality of thyroid function that cannot be maintained in the normal range with medication.
  • Concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin (Coumadin) up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections.
  • Drug having proarrhythmic potential (terfenadine, quinidine,procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide).
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Abnormal cardiac function with abnormal 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTC grade2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
  • Symptomatic brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease.
  • Current treatment with any other investigational medicinal product.
  • Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
  • Pregnancy or breastfeeding.
  • 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 patient inappropriate for entry into this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hôpital Beaujon

    Clichy, 92118

  • Hôpital privé Jean Mermoz

    Lyon, 69008

  • CHU La Timone

    Marseille, 13005

  • Hôpital Saint Antoine

    Paris, 75012

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma

For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered as the reference treatment in first line chemotherapy. However, the outcomes of these patients remain limited and therefore more effective drugs are warranted. The context of the disease and current data on sunitinib suggest that sunitinib may have activity in patients with advanced non resectable cholangiocarcinoma.

Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity of sunitinib in such a patient population.

Read the detailed description

The primary objective is to evaluate the overall survival of patients with advanced and unresectable cholangiocarcinoma treated continuously by sunitinib as second line at the dose of 37.5 mg per day, after one line of chemotherapy and to determine whether sunitinib deserves further studies in this indication.

The secondary objectives are

  • To evaluate the criteria of efficacy
  • To evaluate the effects of sunitinib on tumor angiogenesis
  • To characterize the safety profile of sunitinib
  • To identify markers associated with response to sunitinib
Being tested
Sunitinib
Keywords
Cholangiocarcinoma
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • SunitinibDrug

    Also called sutent

    sunitinib dose :37.5mg/day

Study groups in NCT01718327
Study groupRoleWhat they receive
open label, single armExperimentalsingle arm: sunitinib until progresion or unacceptable toxicity
Receives: Drug: Sunitinib

What is being measured

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

  1. Overall survival

    to evaluate the overall survival of patients with advanced and unresectable cholangiocarcinoma treated continuously by sunitinib as second line at the dose of 37.5 mg per day, after one line of chemotherapy and to determine whether sunitinib deserves further studies in this indication.

    Measured: time interval from first sunitinib dose to the date of death as a result of any cause assessed up to 3 years

Secondary outcomes (4)

  1. To evaluate the criteria of efficacy (PFS, ORR)

    Criteria of efficacy will be determined by:

    • The time to progression under treatment defined as time from first sunitinib dose to documented disease progression or death due to any cause.
    • The objective response rate (ORR) defined as the percentage of all patients who experienced a confirmed complete response (CR) and partial response (PR) based on RECIST criteria. The best overall response, defined as the best response recorded from the start of the treatment until disease progression/recurrence, will be considered.

    Measured: time interval from first sunitinib dose to documented disease progression or death due to any cause, assessed up to 3 years after the beginning of the study

  2. To evaluate the effects of sunitinib on tumor angiogenesis

    The effects of sunitinib on tumor angiogenesis will be determined using the following imaging techniques:

    • Tumor density modification assessed on CT-scan
    • The functional response according to modifications of vascular permeability assessed by either dynamic contrast-enhanced (DCE) magnetic resonance imaging parameters and/or diffusion MRI.

    Measured: Time interval from baseline to the end of treatment, an expected average of 6 months

  3. To characterize the safety profile of sunitinib (collection of AEs)

    Safety will be determined in this patient population by the evaluation of adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events.

    In order to ensure complete safety data collection, all AEs occurring during the study, including any pre- and post-treatment periods required by the protocol must be recorded.

    The period of observation for this study is from signature of informed consent or visit 1 to 1 month after last study drug administration.

    Post-treatment follow up (including assessment/follow-up of adverse events) will be performed every 2 months

    Measured: Time interval from study entry to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study, assessed up to 7 months after the beginning of the study

  4. To identify markers associated with response to sunitinib

    markers

    Measured: Time interval from baseline to the end of treatment, an expected average of 6 months

Timeline

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

  1. First posted31 Oct 2012 (estimated)
  2. Study start1 Sep 2011
  3. Primary completion17 Nov 2016
  4. Study completion17 Nov 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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01718327
Sponsor's protocol ID
SUN-CK D09-2
Other IDs
2011-000073-30
Acronym
SUN-CK
Status last verified
Jan 2017
First submitted
22 Oct 2012
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Gros L, Bouattour M, Dumont C, Dahan L, Malka D, Tijeras-Raballand A, De Gramont A, Ronot M, Dreyer C, Neuzillet C, Bourget P, Hadengue A, Roldan N, Garcia-Larnicol ML, Chibaudel B, Raymond E, Faivre S. Sunitinib as Second-Line Treatment in Advanced Intrahepatic Cholangiocarcinoma: Results From the SUN-CK GERCOR Phase II Trial. Liver Int. 2025 Aug;45(8):e70196. doi: 10.1111/liv.70196.

    PubMed 40631456

  • Dreyer C, Sablin MP, Bouattour M, Neuzillet C, Ronot M, Dokmak S, Belghiti J, Guedj N, Paradis V, Raymond E, Faivre S. Disease control with sunitinib in advanced intrahepatic cholangiocarcinoma resistant to gemcitabine-oxaliplatin chemotherapy. World J Hepatol. 2015 Apr 28;7(6):910-5. doi: 10.4254/wjh.v7.i6.910.

    PubMed 25937868

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Unresectable and Advanced Cholangiocarcinoma, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.

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 21 inclusion and 17 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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?

Overall survival (time frame: time interval from first sunitinib dose to the date of death as a result of any cause assessed up to 3 years). 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 NCT01718327, which also lists 2 linked publications.

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 31 Jan 2017.

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