AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT03604679

SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors

A Phase 1 study testing SyB C-0501 in people with Advanced Solid Tumor, run by SymBio Pharmaceuticals 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 study is an open-label, multicenter, phase 1 study of SyB C-0501 by continuous daily oral administration in patients with advanced solid tumors, who have previously received anticancer therapy and consists of two parts. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SyB C-0501
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesJapan
Study dates
24 May 2018to 11 Sep 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 20 years of age or greater at the time of informed consent
  • Part 1: Patients with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies or without standard therapies.
  • Part 2: patients with advanced solid tumors* refractory to standard therapies or without standard therapies.
  • *metastatic breast cancer, small cell lung cancer and other tumors decided based on the Part 1 results
  • ECOG performance status 0-1
  • Patients with adequate bone marrow, liver, renal, cardiac and pulmonary function as assessed by the following:
Show all 19Show fewer
  • Absolute neutrophil count (ANC) ≥ 1500/μL, who has not received supportive care of treatment with GCS within 2 weeks before the entry
  • Platelet count ≥ 100,000/μL and Hemoglobin ≥ 9g/dL in patients received no blood transfusions within 2 weeks before the study entry
  • Serum creatinine ≤ 1.5 x upper limit normal (ULN) or estimated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation
  • Serum total bilirubin ≤ 1.5 x ULN in patients not suffering from Gilbert's syndrome
  • ALT and AST ≤ 3.0 x ULN (≤ 5.0 x ULN if liver lesions)
  • 12-lead ECG normal
  • LVEF ≥ 55% by echocardiography
  • SpO2 ≥ 95% or PaO2 ≥ 65mmHg
  • Acute toxicity in prior treatment has recovered to baseline or CTCAE Grade 0-1 except the adverse events that, in the judgment of the investigator or sub-investigator, would not provide safety risks in the study.
  • Serum/urine pregnancy tests performed before the study entry are negative.
  • Male and female patients of childbearing potential should give their consent to use adequate contraceptive measures during the study and 180 days after completing study treatment.
  • Provision of written, signed and dated informed consent by the patient or legally acceptable representative after the receipt of adequate information regarding the study
  • Ability to understand participation in the study, visiting/treatment plan, sampling/analyses and other study procedures; and willingness to follow them

Who cannot join

  • Active, uncontrollable or symptomatic metastatic tumors in CNS
  • Complications of interstitial lung disease, pulmonary fibrosis and emphysema diagnosed by chest-X ray or CT scan
  • Medical history of radiation, idiopathic or drug-induced pneumonitis
  • Major surgery within 4 weeks before study entry or planning it within 4 weeks
  • Treatment with immunotherapy, therapeutic antibody or biologics within 4 weeks or their 5 half-lives before study entry, whichever is longer
  • Treatment with cytocidal chemotherapy or hormonal therapy within 14 days
Show all 19Show fewer
  • Radiotherapy within 4 weeks before study entry
  • Palliative radiotherapy to control metastatic bone pain within 7 days before study entry
  • Malabsorption syndrome or full/partial gastric resection
  • Patients intolerable to oral administration in the judgment of the investigator or sub-investigator
  • Patients under following medical treatment
  • Anticancer therapy approved for advanced cancers
  • Study treatment in other clinical trials
  • Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) detected in blood test
  • Lactating women
  • Medical history of allergy to the agents similar to the investigational drug such as alkylating agents or purine nucleoside derivatives
  • Medical history of allergy to Polyoxyl 40 hydrogenated castor oil or gelatin capsule
  • Severe acute or chronic physical/mental condition or laboratory abnormalities which could interfere with evaluation of study treatment or results, or which is likely to progress/worsen due to the participation in the study or administration of SyB C-0501
  • Any condition that, in the opinion of the investigator or sub-investigator, makes the patient inappropriate for the study participation.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Research Site

    Chuo-ku, Tokyo

  • Research Site

    Sayama

Other trials in Japan

About this study

Official title: A Multicenter, Open-label, Phase I Study of SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors:

This study is an open-label, multicenter, phase 1 study of SyB C-0501 by continuous daily oral administration in patients with advanced solid tumors, who have previously received anticancer therapy and consists of two parts. Part 1 is a dose escalation study to evaluate tolerability of SyB C-0501 in the patients, and to find the maximum tolerated dose (MTD), recommended dose (RD) and optimum dosing schedule. Part 2 is being done to evaluate safety and anti-tumor activity of SyB C-0501 preliminarily at RD, and to assess its target cancer exploratory.

Being tested
SyB C-0501

What participants receive

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

  • SyB C-0501Drug

    Also called bendamustine hydrochloride

    Specified dose on specified days

Study groups in NCT03604679
Study groupRoleWhat they receive
SyB C-0501ExperimentalSyB C-0501 (Oral Bendamustine) will be administered orally once a day (specified dose). The treatment period of 21 days (Cohort 1; 7 days of administration + 14 days of observation or Cohort 2; 14 days of administration + 7 days of observation or Cohort 3; 21 days of administration) constitutes 1 cycle. Part 1: dose escalation to determine MTD, RD and dosing schedule Part 2: dose expansion at RD
Receives: Drug: SyB C-0501

What is being measured

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

  1. Identification of Dose-Limiting Toxicity (DLT) and Number of Subjects with DLT in Each Cohort/Level

    Based on the number of patients with DLT and administration dose in each cohort, recommended dosage will be defined for the following clinical phase. A DLT is defined as an adverse event that occurred during the Cycle 1, for which a causality with the investigational products (IP) cannot be ruled out and meets the DLT criteria of this study.

    Measured: Cycle 1 (Approximately 3 weeks)

  2. Adverse Events (Types, Incidence, severity, Relationship to SyB C-0501)

    Measured: Approximately 2 years

Secondary outcomes (12)

  1. Adverse Events (Types, Incidence, Severity, Relationship to SyB C-0501)

    Measured: Approximately 4 years

  2. Change of laboratory test values and clinical laboratory abnormal values (Incidence, Severity)

    Measured: Approximately 4 years

  3. Maximum concentration (Cmax) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days)

  4. Time to maximum concentration (tmax) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day15 of Cycle 1 (each cycle is 21 days)

  5. Area under the concentration-time curve up to the last time point with detectable plasma concentration (AUC0-last) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days)

  6. Area under the concentration-time curve up to infinity (AUC0-inf) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days)

  7. Elimination half-life (t1/2) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days)

  8. Oral clearance (CL/F) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days)

  9. Apparent volume of distribution (Vd/F) of unchanged bendamustine in plasma

    Measured: Day 1, and Day 8 or Day 15 of Cycle 1 (each cycle is 21 days)

  10. Objective Response Rate (ORR), Clinical benefit rate (CBR) and Progression-Free Survival (PFS)

    Measured: Approximately 4 years

  11. Change of laboratory test values and clinical laboratory abnormal values (Incidence, Severity)

    Measured: Approximately 2 years

  12. Objective Response Rate (ORR), Clinical benefit rate (CBR) and Progression-Free Survival (PFS)

    Measured: Approximately 2 years

Timeline

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

  1. First posted27 Jul 2018
  2. Study start24 May 2018
  3. Primary completion11 Sep 2020
  4. Study completion11 Sep 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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03604679
Sponsor's protocol ID
2017003
Status last verified
Apr 2021
First submitted
30 May 2018
Last updated
27 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Shimizu T, Nakagawa K, Hayashi H, Iwasa T, Kawakami H, Watanabe S, Yamamoto N, Yonemori K, Koyama T, Sato J, Tamura K, Kikuchi K, Akaike K, Takeda S, Takeda M. Oral formulation of bendamustine hydrochloride for patients with advanced solid tumors; a phase 1 study. Invest New Drugs. 2023 Feb;41(1):1-12. doi: 10.1007/s10637-022-01307-6. Epub 2022 Nov 4.

    PubMed 36331674

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SyB C-0501 in people with Advanced Solid Tumor, run by SymBio Pharmaceuticals 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 19 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 27 Apr 2021. 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?

Identification of Dose-Limiting Toxicity (DLT) and Number of Subjects with DLT in Each Cohort/Level (time frame: Cycle 1 (Approximately 3 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 NCT03604679, which also lists 1 linked publication.

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 27 Apr 2021.

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