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Metastatic Colorectal CancerPhase 1/2NCT02851004

Special Combination of BBI608 and Pembrolizumab

A Phase 1/2 study testing Napabucasin and Pembrolizumab in people with Metastatic Colorectal Cancer, run by Takayuki Yoshino at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

the efficacy and safety of BBI608 in combination with pembrolizumab Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Napabucasin and Pembrolizumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteJapan
Study dates
Oct 2016to 23 Aug 2021
Phase
Phase 1/2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who personally provided written consent to be the subjects of the study
  • Age of 20 years or older on the day of informed consent
  • [Phase Ib] Histologically confirmed gastrointestinal cancer
  • [Phase II] Histologically confirmed colon or rectal cancer that is adenocarcinoma , and identification of at least the KRAS codon 12 and 13 mutation status determined by RAS gene testing. Confirmation of the microsatellite instability (MSI) status.
  • [Additional cohort to the Phase II part] Histologically confirmed colon or rectal cancer that is adenocarcinoma, and identification of RAS mutation status. Identification of CMS 1 or 4 and MSS by screening tests.
  • [Phase Ib] Gastrointestinal cancer not responded to or intolerant of standard chemotherapy
Show all 13Show fewer
  • [Phase II]A history of treatment with one or more regimens of the following standard chemotherapies for metastatic CRC, and being not responded to or tolerated the chemotherapies
  • [Additional cohort to the Phase II part] In accordance with Cohort B in the Phase II part.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
  • Patients with evaluable lesions (Cohort A in Phase II and Phase Ib) or measurable lesions (Cohort B in Phase II and the additional cohort to the Phase II part) specified in the RECIST version 1.1
  • Patients with adequate organ function based on the following laboratory values measured within 7 days before enrollment
  • Women of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients who consent to practice appropriate contraception during the study and for 4 months after the discontinuation of the protocol treatment
  • Patients with an expected survival of at least 3 months

Who cannot join

  • Patients who received chemotherapy, molecular-targeted agents and/or palliative radiotherapy within 2 weeks before the start of the protocol treatment or have not recovered from toxicity caused by previous treatment
  • Patients who underwent general anesthesia, surgery requiring hospitalization and extensive radiotherapy within 4 weeks before the start of the protocol treatment or minor surgery such as implantation of a central venous access device within two weeks before the start of the protocol treatment
  • Patients with active central nervous system metastases or carcinomatous meningitis.
  • Pregnant or lactating women
  • Patients who are unable or not willing to take BBI608 capsules every day
  • Patients with gastrointestinal disease markedly interfering with the absorption of oral formulations as judged by the investigator
Show all 17Show fewer
  • Patients with active autoimmune disease requiring systemic treatment within 2 years before the start of the protocol treatment.
  • Patients with a history or signs of interstitial lung disease or active non-infectious pneumonitis
  • Patients who underwent organ or bone marrow transplantation
  • Patients who received a live vaccine within 30 days before the start of the protocol treatment
  • Patients who participated in another clinical study within 4 weeks before the start of the protocol treatment and used or using an investigational drug or device
  • Patients who previously received immunotherapy with drugs targeting PD-1, PD-L1 and/or PD-L2 or BBI608 therapy, or took part in a clinical study of pembrolizumab or BBI608
  • Patients with uncontrollable complications
  • Patients with a history of other malignancies within 3 years before the start of the protocol treatment.
  • Patients with clinically significant Electrocardiogram (ECG) abnormalities
  • Patients with a history of Human Immunodeficiency Virus (HIV)
  • Patients with active hepatitis B or C

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

Official title: A Phase Ib/II Study of BBI608 in Combination With Pembrolizumab in Patients With Metastatic Colorectal Cancer

the efficacy and safety of BBI608 in combination with pembrolizumab

Read the detailed description

This is a multicenter, open-label Phase Ib/II study to exploratively evaluate the efficacy and safety of BBI608 in combination with pembrolizumab in patients with metastatic colorectal cancer (CRC) not responded to or intolerant of standard chemotherapy.The same analysis will be performed for the additional cohort to the Phase II part, consisting of patients with metastatic CMS 1 or 4, MMS, CRC not responsive to or intolerant of standard chemotherapy.

Being tested
Napabucasin, Pembrolizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • NapabucasinDrug

    1 cycle is 21days.

    BBI608: Oral administration at a dose of 240mg or 480 mg twice daily (BID), every day.

    [Additional cohort to the Phase II part] Oral administration at a dose of 240mg mg BID, every day

    The therapy will be repeated until meeting the discontinuation criteria.

  • PembrolizumabDrug

    1 cycle is 21days.

    Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle

    [Additional cohort to the Phase II part] Administration at a dose of 200 mg/body on Day 1 of each cycle.

    The therapy will be repeated until meeting the discontinuation criteria.

Study groups in NCT02851004
Study groupRoleWhat they receive
BBI608 + PembrolizumabExperimentalBBI608 and Pembrolizumab
Receives: Drug: Napabucasin; Drug: Pembrolizumab

What is being measured

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

  1. irORR

    Immune-related objective response rate determined by their Response Evaluation Criteria In Solid Tumors (RESIST): for the Phase II part

    Measured: 2 years

  2. ORR

    Objective response rate determined by RECIST version 1.1: for additional cohort to the Phase II part

    Measured: 1 year

Secondary outcomes (10)

  1. irPFS

    Immune-related progression free survival rate at week 12 determined by the irRECIST

    Measured: 12 weeks

  2. ORR

    Objective response rate determined by RECIST version 1.1: for the Phase II part

    Measured: 2 years

  3. irORR

    Immune-related objective response rate determined by their Response Evaluation Criteria In Solid Tumors (RESIST): for additional cohort to the Phase II part

    Measured: 1 year

  4. Progression free survival rate at week 12 determined by the RECIST version 1.1

    PFS

    Measured: 12 weeks

  5. PFS

    Progression free survival

    Measured: 3 years

  6. OS

    Overall survival

    Measured: 4 years

  7. DCR

    Disease Control rate

    Measured: 2 years

  8. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence of adverse events

    Measured: 4 years

  9. Pharmacokinetic

    Area under the blood concentration-time curve (AUC)

    Measured: 2 months

  10. Pharmacokinetic

    CmaxPeak Plasma Concentration (Cmax)

    Measured: 2 months

Timeline

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

  1. First posted1 Aug 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion3 Feb 2020
  4. Study completion23 Aug 2021

Why it stopped: On the request of the investigational drug provider. No subjects were newly enrolled in the additional cohort as they were preparing to resume enrollment in the additional cohort. Currently, it is preparing the creation of clinical study report.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
\[Phase Ib\] 6 to 9 patients \[Phase II\] Cohort A (MSI-H): 10 patients Cohort B (MSS): 40 patients Including patients with metastatic CRC treated at the recommended dose (RD) level in the Phase Ib part who meet criteria for the full analysis set (FAS) \[Additional cohort to the Phase II part\] 1. st stage: CMS 1 or 4, MSS right-side colon cancers\*: 10 patients 2. nd stage: 1. : If no patient shows a partial or complete response in the 1st stage, the study will be prematurely terminated. 2. : If 1 or 2 patients show a partial or complete response in the 1st stage, 19 patients with CMS 1 or 4, MSS right-side colon cancers will be enrolled additionally. 3. : If 3 or more patients show a partial or complete response in the 1st stage, 19 patients with CMS 1 or 4, MSS right-side colon cancers and 10 patients with CMS 1 or 4, MSS left-side colon cancers\* will be enrolled additionally.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02851004
Sponsor's protocol ID
EPOC1503
Status last verified
Aug 2021
First submitted
14 Jul 2016
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Napabucasin and Pembrolizumab in people with Metastatic Colorectal Cancer, run by Takayuki Yoshino at 1 site in Japan.

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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 5 Sep 2021. 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 Japan. 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 combined 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.

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 was stopped early (reason given: On the request of the investigational drug provider. No subjects were newly enrolled in the additional cohort as they were preparing to resume enrollment in the additional cohort. Currently, it is preparing the creation of clinical study report.). Results are not available in the source record.

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?

irORR (time frame: 2 years). 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 NCT02851004.

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 5 Sep 2021.

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