AzTrials
AzTrials

Metastatic Colorectal CancerPhase 1NCT02641873

A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

A Phase 1 study testing BBI608, 5-FU and Irinotecan in people with Metastatic Colorectal Cancer, run by Sumitomo Pharma Co., Ltd. at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI + Bavacizumab. This study population is adult Japanese patients with metastatic colorectal cancers in FOLFIRI + Bevacizumab combination therapy. 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?
BBI608, 5-FU and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesJapan
Study dates
Dec 2015to Jan 2017
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A histologically confirmed advanced unresectable, metastatic or recurrent colorectal carcinoma
  • Evaluable patient by RECISTversion 1.1
  • Stage IV
  • ≥ 20 years of age
  • Life expectancy ≥ 3 months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Show all 17Show fewer
  • Patients with following organ function within 14 days before enrollment (on the basis of the most recent data during the period if multiple data are available)
  • Hemoglobin (Hg) ≥ 9.0 g/dL
  • Neutrophil count ≥ 1.5 x 103/μL
  • Platelet count ≥ 10 x 104/μL
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases ]
  • Total bilirubin ≤ 1.5 × institutional ULN [≤ 2 × ULN in presence of liver metastases ]
  • Creatinine ≤ 1.5 × institutional ULN
  • Proteinuria by dipstick urine analysis ≤ 1+. [ UPCR (Urine Albumin-to-Creatinine Ratio) ≤ 1, or protein volume of 24-hour urine collection ≤ 1 g, in the case of patients with a 2+ urine dipstick reading]
  • For female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose or 6 months after Bevacizumab treatment.. For male patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 90 days after the last protocol treatment dose or 6 months after Bevacizumab treatment
  • Females of childbearing potential have a negative urine pregnancy test
  • Patients who have provided written voluntary consent in person to participate in this study after fully receiving and understanding the information about this study, including study

Who cannot join

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or hormone therapy, or heart therapy within 21 days of the first dose of BBI608
  • Major surgery within 28 days prior to first dose
  • Have had a brain metastases with a symptom or requiring treatment
  • Have had coinstantaneously active multiple primary cancer
  • Have had a carcinomatous pleural effusion, ascites, or cardiac effusion requiring treatment
  • Crohn's disease, ulcerative colitis, small intestine resection, diarrhea (watery diarrhea), paralysis intestinal, Intestinal obstruction
Show all 23Show fewer
  • Gastrointestinal perforation, tracheo-oesophageal fistula, fistula
  • Unable or unwilling to swallow BBI608 capsules
  • Uncontrolled inter-current illness (such as Grade 3 active infection, or serious respiratory disease)
  • Uncontrolled hypertension
  • Patients with recent history of hemoptysis of more than 2.5 mL of red blood within 28days before the enrolment
  • Abnormal ECGs which are clinically significant within 28 days before enrolment
  • Patients who are New York Heart Association (NYHA) functional classes III, or IV, or unstable angina
  • Patients newly expressing angina within three months (90 days) before the enrolment
  • Have had myocardial infarction within six months (180 days)before the enrolment
  • Administrating with antiarrhythmic drug
  • Patients who are planning to breast-feeding by whichever 30 days after the last administration of BBI608 or by 6 months after the last administration of Bevacizumab
  • Patients of pregnancy or possibility of pregnancy at current time or possibility of pregnancy within 6 months after the last administration of Bevacizumab
  • Have received other investigational products or not finished the assessment in any clinical study within 28 days before enrollment
  • Known severe hypersensitivity to 5-FU/ levofolinate/ irinotecan/Bevacizumab
  • Administration of atazanavir sulfate
  • Prior treatment with BBI608
  • Ineligible for participation in the study in the opinion of the Investigators

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Cancer Center Hospital East

    Kashiwa, Chiba

  • Aichi Cancer Center Hospital

    Nagoya, Aichi

Other trials in Japan

About this study

Official title: A Phase I Study of BBI608 Administered With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI + Bavacizumab. This study population is adult Japanese patients with metastatic colorectal cancers in FOLFIRI + Bevacizumab combination therapy.

Being tested
BBI608, 5-FU, Irinotecan, Levofolinate, Bevacizumab
Keywords
metastatic Colorectal Cancer, mCRC
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • BBI608Drug

    240 mg twice daily (480 mg total daily dose)

  • 5-FUDrug

    400 mg/m2 bolus will be administered intravenously immediately following irinotecan/levofolinate infusion, followed by 1200 mg/m2/day (total 2400 mg/m2) continuous infusion per cycle(14 days).

  • IrinotecanDrug

    180 mg/m2 together with levofolinate will be administered intravenously per cycle(14 days).

  • LevofolinateDrug

    200 mg/m2 together with Irinotecan will be administered intravenously per cycle(14 days).

  • BevacizumabDrug

    5 mg/kg will be administered intravenously following irinotecan/levofolinate infusion per cycle(14 days).

Study groups in NCT02641873
Study groupRoleWhat they receive
BBI608 + FOLFIRI +BevacizumabExperimentalNot described
Receives: Drug: BBI608; Drug: 5-FU; Drug: Irinotecan; Drug: Levofolinate; Drug: Bevacizumab

What is being measured

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

  1. Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]

    Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs)

    Measured: 12 months

  2. Number of participants with Dose-limiting toxicities (DLT) [Safety and Tolerability]

    Safety and tolerability assessed by determination of unacceptable toxicity in patients.

    Measured: 12 months

  3. Cmax (Peak plasma concentration)

    Cmax (Peak plasma concentration)

    Measured: Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose.

  4. AUC0-24h (Area under the plasma concentration versus time curve)

    AUC0-24h (Area under the plasma concentration versus time curve)

    Measured: Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose.

Secondary outcomes (2)

  1. Preliminary anti-tumour activity

    The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST for patients with metastatic colorectal cancer.

    Measured: 6 months(an expected average)

  2. Progression Free Survival (PFS)

    Participants follow-up for progression free survival will occur. Maximum follow-up time is 12 months after the initial administration of the last subject.

    Measured: 12 months

Timeline

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

  1. First posted30 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016
  4. Study completionJan 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641873
Sponsor's protocol ID
D8809001
Status last verified
Apr 2022
First submitted
21 Dec 2015
Last updated
12 Apr 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BBI608, 5-FU and Irinotecan in people with Metastatic Colorectal Cancer, run by Sumitomo Pharma Co., Ltd. at 2 sites 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 17 inclusion and 23 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability] (time frame: 12 months). The study lists 4 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 NCT02641873.

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 12 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in