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Hepatocellular CarcinomaPhase 2NCT02232633

A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer

A Phase 2 study testing BBI503 in people with Hepatocellular Carcinoma and Cholangiocarcinoma, run by Sumitomo Pharma America, Inc. at 3 sites in Canada.

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 an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced hepatobiliary cancer who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, Cholangiocarcinoma
What is being tested?
BBI503
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
3 sitesCanada
Study dates
Feb 2015to 14 Dec 2017
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

  • Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
  • Histologically or cytologically confirmed hepatocellular carcinoma or cholangiocarcinoma, that is metastatic, unresectable, or recurrent; and for which no currently approved, standard anti-cancer treatment option is available. Patients must have received standard of care treatment prior to enrollment.
  • ≥ 18 years of age
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
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  • Females of childbearing potential must have a negative serum pregnancy test
  • Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 5.0x the upper limit of normal (ULN)
  • Hemoglobin > 8.0 g/dL
  • Total bilirubin ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN or creatinine clearance > 50 mL/min according to the Cockcroft-Gault estimation.
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 60 x 10^9/L
  • Life expectancy ≥ 3 months
  • A patient with hepatocellular carcinoma (HCC) which has arisen out of any medical context must also meet the following criteria:
  • Must not be a candidate for potentially curative resection
  • Must be Child-Pugh class A or B7 (i.e., in order to be eligible, the total Child-Pugh score for a patient must be ≤ 7)
  • Must have received prior treatment with sorafenib; and have had either disease progression during treatment or have had documented intolerance to sorafenib such that further treatment with sorafenib is not possible.
  • Patients with uncontrolled massive ascites or presence of hepatic encephalopathy within four (4) weeks of first dose are excluded
  • A patient with confirmed cholangiocarcinoma of any type must also meet the following criteria:
  • Must have disease which is not amenable to surgical, radiation, or combined modality therapy with curative intent
  • Must have received prior treatment with gemcitabine, either alone or in combination with a platinum agent. Patients who are not eligible for gemcitabine must have received an alternate first-line systemic chemotherapy regimen

Who cannot join

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI503. Patients may begin BBI503 on a date determined by the investigator and medical monitor for the sponsor provided there is a minimum of 7 days since last receiving anti-cancer treatment, and that all prior treatment-related adverse events (AEs) have resolved or have been deemed irreversible.
  • Major surgery within 4 weeks prior to first dose (requiring general anesthesia and/or inpatient hospitalization for recovery).
  • Any known symptomatic or untreated brain metastases requiring increase of steroid dose within 2 weeks prior to starting on study. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
  • Pregnant or breastfeeding
  • Significant gastrointestinal disorder(s), in the opinion of the treating investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection); such that absorption of oral medications may be impaired.
  • Unable or unwilling to swallow BBI503 capsules daily
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  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (e.g. no reliable transportation).
  • Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current hepatobiliary malignancy.
  • Abnormal ECGs which are clinically significant such as QT prolongation - QTc > 480 msec, clinically significant cardiac enlargement or hypertrophy, new bundle branch block, or signs of active ischemia. Patients with evidence of prior infarction who are New York Heart Association (NYHA) functional class II, III, or IV are excluded, as are patients with marked arrhythmia such as Wolff Parkinson White pattern or complete atrioventricular (AV) dissociation.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • University of Calgary

    Calgary, Alberta, T2N 4N2

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Hospital

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer

This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced hepatobiliary cancer who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy.

Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study treatment.

Being tested
BBI503
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma

What participants receive

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

  • BBI503Drug

    Also called Amcasertib, BBI-503, BB503

Study groups in NCT02232633
Study groupRoleWhat they receive
BBI503ExperimentalBBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily
Receives: Drug: BBI503

What is being measured

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

  1. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1.

    Measured: 8 weeks

  2. Progression free survival (PFS)

    Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.

    Measured: 24 months

  3. Overall survival (OS)

    Defined as the time from enrollment to death due to any cause.

    Measured: 24 months

  4. Pharmacodynamics (biomarkers) of BBI503 when tumor biopsy is possible

    Measured: baseline, 4 weeks

  5. Number of Patients with Adverse Events

    All patients who have received at least one dose of BBI503 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.

    Measured: 24 months

Timeline

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

  1. First posted5 Sep 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completion14 Dec 2017
  4. Study completion14 Dec 2017

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02232633
Sponsor's protocol ID
BBI503-205b
Other IDs
BBI503-205HCC
Status last verified
Nov 2023
First submitted
3 Sep 2014
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BBI503 in people with Hepatocellular Carcinoma and Cholangiocarcinoma, run by Sumitomo Pharma America, Inc. at 3 sites in Canada.

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 9 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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?

Disease Control Rate (DCR) (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 NCT02232633.

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 14 Nov 2023.

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