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ADVANCED HEPATOCELLULAR CARCINOMA (HCC)Phase 1NCT02906397

Galunisertib (LY2157299) Plus Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma (HCC)

A Phase 1 study testing Galunisertib 150mg by mouth twice a day and Stereotactic Body Radiotherapy (SBRT) in people with ADVANCED HEPATOCELLULAR CARCINOMA (HCC), run by Abramson Cancer Center at Penn Medicine at 1 site 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

To determine the safety and tolerability of galunisertib when combined with Stereotactic Body Radiotherapy (SBRT) (hypofractionated radiation). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ADVANCED HEPATOCELLULAR CARCINOMA (HCC)
What is being tested?
Galunisertib 150mg by mouth twice a day and Stereotactic Body Radiotherapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
30 Mar 2017to 21 Jul 2021
Phase
Phase 1
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

  • Patients must have histologically confirmed hepatocellular carcinoma (HCC) that is inoperable (where surgery is not indicated due to disease extension, co-morbidities or other technical reasons)
  • ≥18 years of age and ability to understand and the willingness to sign a written informed consent document. A legally authorized representative signature in the event that the subject is not able to sign themselves is permitted.
  • Patients must have either not been eligible for sorafenib therapy, have failed sorafenib therapy, have discontinued sorafenib therapy due to intolerable toxicity or have refused sorafenib
  • ECOG performance status ≤2
  • Childs Pugh score of ≤7
  • Life expectancy of at least 12 weeks
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  • Must be able to swallow tablets
  • Must be willing to comply with protocol procedures (including completion of diaries and outcome measures)
  • Local or loco-regional therapy (ie surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) must have been completed ≥4 weeks prior to enrollment
  • Must be willing to undergo a pretreatment biopsy
  • A history of prior radiotherapy is permitted, as long as the prior radiated site is not overlapping with the site of planned SBRT
  • Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • An index lesion measuring between 1cm-10cm that is amenable to hypofractionated radiation therapy at the discretion of the treating radiation oncologist
  • Women of childbearing potential must have a negative serum pregnancy test performed at screening
  • Subjects must use an approved contraceptive method (for example, intrauterine device, birth control pills or barrier device) which has an expected failure rate of <1%, if appropriate for at least 3 months after the last dose of galunisertib.
  • Patients who are HIV-positive are eligible if:
  • CD4+ cell count is greater or equal to 250cells/mm3.
  • If patient is on retroviral therapy, there must be minimal interactions or -overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment.
  • No history of non-malignancy AIDS defining conditions other than low CD4+ count.
  • Probable long-term survival with HIV if cancer were not present.
  • Must have adequate organ and hematopoietic function as defined below:
  • Laboratory Test Required Value Absolute neutrophil count ≥1.5 x 10^9/L Platelet count ≥100 x 10^9/L Hemoglobin ≥9.0 x 10^9/L Alanine transaminase ≤2.5 x ULN Aspartate aminotransferase ≤2.5 x ULN Serum creatinine or CrCl ≤2.0 x ULN Total Bilirubin ≤1.5 x ULN

Who cannot join

  • Any history of a serious medical or psychiatric condition that would prevent the patient from signing the informed consent form
  • Pregnant or breastfeeding women.
  • Use of any other chemotherapy, radiotherapy or experimental drug within 4 weeks prior to first study treatment date
  • A history of radiotherapy that, in the opinion of the investigator, would render SBRT unsafe to administer
  • Those who have not recovered from adverse events ≤ grade 1 secondary to therapy administered >4 weeks prior to first study treatment date, with the exception of stable grade 2 neuropathy
  • Subjects may not receive concomitant anticancer agents. Antiviral agents aimed at treating infectious hepatitis are permitted
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  • History of or suspected hypersensitivity to radiation or to galunisertib
  • Uncontrolled ascites
  • Subjects with a history of or evidence of cardiac disease during screening, defined as any one of the following: myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, uncontrolled hypertension.
  • Subjects with a documented major ECG abnormalities (not responding to medical treatments) or not clinically stable for at least 6 months.
  • Subjects with major abnormalities documented by ECHO with Doppler (for example, moderate or severe heart valve function defect) that is not stable for at least 6 months.. Note: Left ventricular [LV] ejection fraction <50% is allowed only if clinically stable for at least 6 months (evaluation based on the institutional lower limit of normal).
  • Subjects with a predisposition toward developing aneurysms of the ascending aorta or aortic stress including a family history of aneurysms, Marfan Syndrome, Ehlers Danlos Type IV, bicuspid aortic valve or evidence of damage to the large vessels of the heart documented by previously obtained or screening CT scan/MRI
  • Subjects with uncontrolled brain metastases. Subjects with brain metastases must have stable neurological status following local therapy (surgery or radiation) for at least 4 weeks prior to first study treatment and must be off steroids
  • Any concurrent condition requiring the continued or anticipated use of systemic steroids beyond physiologic replacement dosing (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low-dose methotrexate). All other systemic corticosteroids above physiologic replacement dosing must be discontinued at least 4 weeks prior to first study treatment
  • Active drug or alcohol use or dependence as documented in the chart that, in the opinion of the investigator, would interfere with adherence to study requirements
  • A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
  • Prior malignancies. Patients with carcinoma in-situ of any origin and patients with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma) as judged by the Lilly clinical research physician (CRP), are eligible.
  • Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint
  • Any other conditions judged by the investigator that would limit the evaluation of the subject

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Pilot Study of Galunisertib (LY2157299) Plus Stereotactic Body Radiotherapy (SBRT) in Patients With Advanced Hepatocellular Carcinoma (HCC)

To determine the safety and tolerability of galunisertib when combined with Stereotactic Body Radiotherapy (SBRT) (hypofractionated radiation).

Being tested
Galunisertib 150mg by mouth twice a day, Stereotactic Body Radiotherapy (SBRT)

What participants receive

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

  • Galunisertib 150mg by mouth twice a dayDrug

    Also called LY2157299

    on days 1-14 of 28 day cycles

  • Stereotactic Body Radiotherapy (SBRT)Radiation

    18GY delivered in one fraction between C1D15 and C1D28

Study groups in NCT02906397
Study groupRoleWhat they receive
Experimental: Galunisertib/SBRTExperimentalGalunisertib (LY2157299) 150mg by mouth twice a day on days 1-14 of 28 day cycles SBRT 18Gy, delivered in one fraction between Cycle 1 D15 and D28
Receives: Drug: Galunisertib 150mg by mouth twice a day; Radiation: Stereotactic Body Radiotherapy (SBRT)

What is being measured

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

  1. Safety based upon standard laboratory and clinical adverse event monitoring

    Number of participants with treatment-related adverse events as assessed by CTCAE v4

    Measured: Cycle 1 Day 15 through date of progression assessed up to 90 months

Secondary outcomes (5)

  1. Progression free survival (PFS) who are receiving the combination of galunisertib plus SBRT as compared to the PFS of Galunisertib alone in historical controls.

    From Cycle 1 Day 1 to progression of disease

    Measured: Cycle 1 Day 15 through date of progression assessed up to 90 months

  2. Response rate

    by conventional CT and MRI

    Measured: Cycle 3 Day 1 and every 8 weeks thereafter up to 90 months

  3. Overall survival (OS)

    start of treatment to death due to any cause or last patient contact alive

    Measured: Cycle 1 Day 1 to death due to any cause or last patient contact alive up to 90 months

  4. Inhibition of TGF-β signaling by intervention as evidenced by downstream changes in this pathway

    Measured: Cycle 1 Day 15 through date of progression assessed up to 90 months

  5. Promotion of anti-tumor immunity with addition of intervention to SBRT

    Measured: Cycle 1 Day 15 through date of progression assessed up to 90 months

Timeline

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

  1. First posted20 Sep 2016 (estimated)
  2. Study start30 Mar 2017
  3. Primary completion21 Jul 2021
  4. Study completion21 Jul 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02906397
Sponsor's protocol ID
826247 (UPCC 24216)
Status last verified
Mar 2022
First submitted
15 Sep 2016
Last updated
25 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Galunisertib 150mg by mouth twice a day and Stereotactic Body Radiotherapy (SBRT) in people with ADVANCED HEPATOCELLULAR CARCINOMA (HCC), run by Abramson Cancer Center at Penn Medicine at 1 site 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 19 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 25 Mar 2022. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety based upon standard laboratory and clinical adverse event monitoring (time frame: Cycle 1 Day 15 through date of progression assessed up to 90 months). 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 NCT02906397.

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 25 Mar 2022.

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