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

NCT02428855 | Completed Phase 2 Results DMC

• 1 other identifier: 15-007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (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.

  8 Weeks

Secondary Outcomes (3)

• Median Progression Free Survival (PFS)

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

• Overall Survival

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

• Number of Participants With Adverse Events

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

Study Arms (1)

Dasatinib

EXPERIMENTAL

Patients 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

Drug: Dasatinib

Interventions

Dasatinib DRUG

Also known as: SPRYCEL ™

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bristol-Myers Squibb: collaborator
• TargetCancer Foundation: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Bruce Giantonio
• Organization: Massachusetts General Hospital

BGIANTONIO@mgh.harvard.edu

617-724-4000

Study Officials

• Bruce Giantonio, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 31, 2020
• Results First Posted: July 31, 2020

Record last verified: 2020-07

Locations

US (2)