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CancerPhase 1NCT02432326

A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors

A Phase 1 study testing BBI608 and BBI503 in people with Cancer and Advanced Solid Tumors, run by Sumitomo Pharma America, Inc. at 11 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 is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Advanced Solid Tumors
What is being tested?
BBI608 and BBI503
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
11 sitesUnited States
Study dates
Apr 2015to Apr 2020
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

  • Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
  • A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard therapies do not exist or are no longer effective
  • Patients must not be considered eligible for a potentially curative resection
  • ≥ 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
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  • 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 dose
  • Females of childbearing potential must have a negative serum pregnancy test
  • Aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × ULN.
  • Patients who do not have hepatocellular carcinoma but who have liver lesions or liver metastases may be eligible if they have AST < 3.5 x ULN and AST < 3.5 x ULN if agreed upon by the investigator and medical monitor for the sponsor.
  • Patients with hepatocellular carcinoma may be eligible provided they have AST and ALT that are ≤ 5.0 x ULN.
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin ≤ 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
  • Patients with hepatocellular carcinoma may be eligible provided they have total bilirubin ≤ 3.0 x ULN and are considered Child-Pugh Class A or Child-Pugh Class B7 (Child-Pugh Class B with a total Child-Pugh score not to exceed 7).
  • Patients with Gilbert's syndrome uncomplicated by other liver disease may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
  • Creatinine ≤ 1.5 × ULN or, for patients with creatinine levels above institutional upper limit of normal, creatinine clearance must be > 60 mL/min/1.73 m^2.
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count ≥ 75 x 10^9/L.
  • Life expectancy ≥ 3 months

Who cannot join

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608 and BBI503. Patients may begin BBI608 and BBI503 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse effects have resolved or have been deemed irreversible
  • Surgery within 4 weeks prior to first dose
  • Any known untreated brain metastases. Treated subjects must be stable 4 weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and must be either off of 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) (e.g., active Crohn's disease or ulcerative colitis, or a history of extensive gastric resection and/or small intestinal resection) such that absorption of oral medications is impaired.
  • Unable or unwilling to swallow BBI608 and/or BBI503 capsules daily
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  • Prior treatment with either BBI608 or BBI503
  • Uncontrolled concurrent 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 on mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
  • Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; and c) other primary solid tumors (with no known active disease present) that, in the opinion of the investigator, will not affect patient outcome in the setting of the current diagnosis
  • Patients with adenocarcinoma of unknown primary are excluded
  • Patients with a diagnosis of two co-existing primary cancers are excluded
  • Abnormal ECGs that are clinically significant such as QT prolongation (QTc > 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block or existing left bundle branch block, or signs of new, active ischemia a. 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

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Texas Oncology - Austin Midtown

    Austin, Texas, 76104

  • University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology - Fort Worth 12th Ave

    Fort Worth, Texas, 76104

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Weill Cornell Medical College

    New York, New York, 10065

  • Texas Oncology, P.A.

    San Antonio, Texas, 78217

  • Texas Oncology, P.A.

    San Antonio, Texas, 78229

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

Other trials in United States

About this study

Official title: A Phase Ib Clinical Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors

This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.

Being tested
BBI608, BBI503
Keywords
Neoplasms
Medical subject headings
Neoplasms

What participants receive

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

  • BBI608Drug

    Also called Napabucasin, BB608, BBI-608

    The BBI608 starting dose is 240 mg twice daily (480 mg total daily). Dose will be decreased to 160 mg twice daily (320 mg total daily) at modification level 2 and 80 mg twice daily (160 mg total daily) at modification level 3. For BBI608 once daily dosing, doses at starting level and modification level 1 are 240 mg once daily, and 480 mg once daily at escalated levels. Dose will be decreased to 160 mg once daily at modification level 2 and 80 mg once daily at modification level 3.

  • BBI503Drug

    Also called BB503, BBI-503

    The BBI503 starting dose is 200 mg once daily. Dose at modification level 1 to 3 will be 100 mg once daily.

Study groups in NCT02432326
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: BBI608; Drug: BBI503

What is being measured

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

  1. Determination of the safety and tolerability of BBI608 and BBI503 when administered in combination by assessing dose-limiting toxicities (DLTs)

    Measured: 4 weeks

  2. Determination of the Recommended Phase 2 Dose of BBI608 and BBI503 when administered in combination based on DLT criteria, pharmacokinetic/pharmacodynamic observations and tolerability overall

    The overall tolerability assessment will include review of persistent grade 2 adverse events and review of adverse events occurring beyond the first cycle.

    Measured: 20 weeks

Secondary outcomes (3)

  1. Pharmacokinetic profile of BBI608 and BBI503 when administered in combination as assessed by maximum plasma concentration and area under the curve.

    Measured: -5min, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hours on day 1, cycles 1 and 2

  2. Pharmacodynamic activity assessed by tumor biopsy

    Tumor Biopsy to provide information on analysis of the effect of BBI608 and BBI503 on cancer stem cells through immunohistochemistry.

    Measured: 4 weeks

  3. Assessment of the preliminary anti-tumor activity by performing tumor assessments

    Measured: 16 weeks

Timeline

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

  1. First posted4 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2019
  4. Study completionApr 2020

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
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02432326
Sponsor's protocol ID
BBI401-101
Status last verified
Nov 2023
First submitted
28 Apr 2015
Last updated
8 Nov 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BBI608 and BBI503 in people with Cancer and Advanced Solid Tumors, run by Sumitomo Pharma America, Inc. at 11 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 19 inclusion and 12 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 8 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 11 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 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?

Determination of the safety and tolerability of BBI608 and BBI503 when administered in combination by assessing dose-limiting toxicities (DLTs) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02432326.

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 8 Nov 2023.

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