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CholangiocarcinomaPhase 2NCT02428855

Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma

A Phase 2 study testing Dasatinib in people with Cholangiocarcinoma, run by Massachusetts General Hospital at 2 sites in United States.

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 research study is studying Dasatinib as a possible treatment for cancer of bile ducts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesUnited States
Study dates
Apr 2015to Feb 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • Participants must have unresectable or metastatic histologically confirmed intrahepatic cholangiocarcinoma
  • Patients must have either IDH1 or IDH2 mutations (any known mutations) based on the SNaPshot platform or other molecular testing platform from either archived tissue or fresh biopsy (tested in CLIA-certified lab)
  • Patients with other biliary tract cancers (extrahepatic or gallbladder cancers) with IDH1 or IDH2 mutations are allowed
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 10 for the evaluation of measureable disease.
  • Participants must have received at least one prior platinum-based regimen for advanced cholangiocarcinoma and had progressive disease or become intolerable to the regimen
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  • Age ≥18 years.
  • Life expectancy of ≥3 months.
  • ECOG performance status 0 or 1 (see Appendix A).
  • Participants must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥ 1,200/mcL
  • Platelets ≥75,000/mcL
  • Hemoglobin ≥9 g/dL
  • Total bilirubin ≤ 2.5 x the upper limit of normal
  • AST (SGOT)/ALT (SGPT) ≤ 5 X institutional upper limit of normal
  • PT/PTT ≤ 1.5 x ULN
  • Creatinine ≤ 1.5 or GFR ≥ 60 mL/min/1.73m2
  • Serum Albumin ≥2.8 g/dl
  • Prior chemoembolization, radiofrequency ablation, or radiation to the liver is allowed as long as the patient has measurable disease outside of the treated area or measurable progression at the site of the treated area
  • Ability to understand and the willingness to sign a written informed consent document.
  • Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s).
  • Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea ≥ 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.

Who cannot join

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Prior treatment with dasatinib
  • Periampullary tumors
  • Chemotherapy, within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or those who have not recovered to less than or equal to grade 1 from adverse events due to agents administered more than 4 weeks earlier.
  • The subject has received radiation therapy:
  • to bone or brain metastasis within 14 days of the first dose of study treatment
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  • to any other site(s) within 28 days of the first dose of study treatment
  • The subject has active brain metastases or epidural disease (Note: Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. (Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.)
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders including
  • Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
  • Concurrent uncontrolled hypertension defined as sustained BP > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
  • Diagnosed or suspected congenital long QT syndrome
  • Any of the following within 6 months before the first dose of study treatment:
  • Unstable angina pectoris
  • Clinically-significant cardiac arrhythmias
  • Stroke (including TIA, or other ischemic event)
  • Myocardial infarction
  • Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), may use either the Fridericia and Bazett's correction
  • Hypokalemia or hypomagnesemia that is not corrected prior to dasatinib administration
  • Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes. The following must be discontinued at least 7 days prior to starting dasatinib to be eligible:quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide,dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine,levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • Other clinically significant disorders such as:
  • active infection requiring systemic treatment within 28 days before the first dose of study treatment
  • serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
  • Patients with known moderate/severe pleural effusions that are unrelated to malignancy or established diagnosis of pulmonary arterial hypertension
  • Concurrent malignancy (other than adequately treated non-melanoma skin cancer, superficial transitional cell carcinoma of the bladder, and cervical carcinoma in situ) diagnosed within the past 3 years or any currently active malignancy
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
  • The subject is unable to swallow tablets
  • Individuals who are known to be HIV-positive are excluded from this study.
  • Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with dasatinib, breastfeeding should be discontinued if the mother is treated with dasatinib. These potential risks may also apply to other agents used in this study.
  • Subjects may not be receiving any other study agents concurrently while on this study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

This research study is studying Dasatinib as a possible treatment for cancer of bile ducts.

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The standard treatment for metastatic cholangiocarcinoma is combination chemotherapy with gemcitabine and cisplatin. The FDA (the U.S. Food and Drug Administration) has not approved dasatinib for your specific disease (Cholangiocarcinoma) but it has been approved for other uses (Chronic Myeloid Leukemia)

Being tested
Dasatinib
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.

Study groups in NCT02428855
Study groupRoleWhat they receive
DasatinibExperimentalPatients with advanced intrahepatic cholangiocarcinoma who have either IDH1 or IDH2 mutations and have received at least one prior platinum containing regimen * Dasatinib, oral, daily, predetermined dosage per cycle * Radiologic Response Assessment every 2 cycles
Receives: Drug: Dasatinib

What is being measured

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

  1. Objective Response Rate (ORR)

    The number of participants that achieved either a complete or partial response, as assessed by Response Criteria in Solid Tumors (RECIST 1.1)

    • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
    • Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: 8 Weeks

Secondary outcomes (3)

  1. Median Progression Free Survival (PFS)

    The median amount of time from registration until disease progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 criteria:

    > Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: From registration until disease progression or death, median duration of 8.7 weeks

  2. Overall Survival

    The median amount of time from registration until death. Participants are censored at the date last known alive.

    Measured: From the time of registration until death, median duration of 37.9 weeks

  3. Number of Participants With Adverse Events

    The number of participants that experienced an adverse event as assessed by Common Toxicology Criteria for Adverse Events (CTCAE 4.0)

    Measured: From the start of treatment until 30 days after the end of treatment, median duration of 3 months

Timeline

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

  1. First posted29 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02428855
Sponsor's protocol ID
15-007
Status last verified
Jul 2020
First submitted
23 Apr 2015
Last updated
31 Jul 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Cholangiocarcinoma, run by Massachusetts General Hospital at 2 sites in United States.

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 22 inclusion and 34 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 31 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: 8 Weeks). 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 NCT02428855.

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 Jul 2020.

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