Advanced or Metastatic CRCPhase 2NCT03906565
Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer
A Phase 2 study testing utidelone injection in people with Advanced or Metastatic CRC, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 5 sites in China.
Trial summary
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic colorectal cancer (CRC) as a phase II trial Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced or Metastatic CRC
- What is being tested?
- utidelone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesChina
- Study dates
- 12 Apr 2019to 31 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed informed consent form; good compliance during the whole study;
- Histologically or cytologically confirmed diagnosis of unresectable advanced or metastatic CRC, not including appendix and anal canal cancer;
- patients failed or intolerable to previous standard second-line treatment for locally advanced or metastatic CRC;
- Patients who have not received previous bevacizumab therapy can be treated in combination with bevacizumab;
- Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy 4 weeks prior to enrollment, with no plan for concurrent other chemotherapy and surgery;
- Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy≥ 3 months;
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- Patients must have at least one measurable target lesion with long axis ≥10 mm on CT or MRI, with short axis ≥15mm for lymph node based on RECIST 1.1, within 4 weeks before enrolment;
- Seven days prior to treatment, haematology test should meet the following requirements (no treatment with G-CSF or TPO 14 days before test): HGB ≥90 g/L, ANC ≥1.5×109/L, PLT ≥100×109/L, WBC ≥3.0×109/L bilirubin ≤1.5×ULN, aspartate transaminase (AST)/ alanine transaminase (ALT) ≤2.5 ×ULN (patients with liver metastasis ≤5xULN), and creatinine clearance ≥50 mL/min;
- Peripheral neuropathy (PN) ≤grade 1 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment; patients with any grade of alopecia are eligible for enrolment;
- Patients with no major organ dysfunctions and heart disease;
- Women and men of childbearing potential must agree to take effective contraceptive measures during the study and within six months after the last treatment. Female patients must have negative urinary pregnancy test within 7 days before the first treatmment (postmenopausal women must have no menstruation for at least 12 months before they are considered unable to conceive);
- Patients must agree to provide blood samples for specific biomarkers study;
- No other concurrent investigational agents during the study.
Who cannot join
- Patients having history of other malignancies except CRC within the last five years, but patients with fully recovered in situ cervix carcinoma or non-melanoma skin cancer are eligible;
- No other anticancer therapies, such as chemotherapy, hormonal therapy, immunotherapy, antibody therapy and radiotherapy, or concurrent other chemotherapy during treatment;
- Patients with uncontrollable brain metastasis, uncontrollable bone metastasis or recent risk of fracture;
- Arterial or venous thrombosis or embolic events such as cerebrovascular accident (including TIA), deep venous thrombosis or pulmonary embolism occurred within one year;
- history of symptomatic heart disease (including unstable angina, myocardial infarction and heart failure);
- history of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
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- Patients with gastrointestinal bleeding, active gastrointestinal ulcer or gastrointestinal obstruction (including paralytic intestinal obstruction). Patients with gastrointestinal perforation or gastrointestinal fistula and abdominal abscess within 6 month;
- Previous partial or total gastrectomy, or major operations (such as laparotomy, thoracotomy and intestinal resection) within 4 weeks；
- Patients with AEs caused by any previous treatment (including systemic and local treatment) that have not yet restored to GRADE 1 (excluding hair loss);
- Patients who are pregnanct (positive pregnancy test), breastfeeding or unwilling to take contraceptive measures during the trial;
- active or uncontrollable infections requiring systemic treatment (except simple urinary or upper respiratory infections) within 2 weeks;
- Severely allergic to Cremophor or having severe adverse events associated with paclitaxel in the past;
- Patients with active pulmonary tuberculosis.Patients having obvious cough blood or hemoptysis of half a teaspoon (2.5 ml) or more during the last one month;
- Existence of uncontrolled diabetes, hypertension, active or uncontrollable infections;
- Patients with serous effusion (such as pleural effusion, pericardial effusion and ascites) with clinical symptoms requiring intervention or stabilization for less than 4 weeks;
- Patients with radiology findings that tumors have invaded important perivascular areas or tumors that are highly likely to invade important blood vessels during treatments which may lead to fatal massive hemorrhage determined by investigators;
- Patients with abnormal coagulation function and tendency to bleed;
- Patients with known HIV infection or untreated active hepatitis B or C;
- Patients with alcohol or drug addiction, or a history of uncontrollable mental illness, lack of or limited legal capacity;
- Patients with other conditions determined by investigators that may affect compliance with study protocol and study evaluation and are not suitable for participating in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tianjin People's Hospital
Tianjin, 300000
About this study
Official title: Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer After Failure or Intolerability to Second-line Standard Treatment
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic colorectal cancer (CRC) as a phase II trial
- Conditions
- Advanced or Metastatic CRC
- Being tested
- utidelone injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utidelone injectionDrug
Also called UTD1 injection
utidelone monotherapy in patients with advanced or metastatic CRC by iv transfusing utidelone injection
| Study group | Role | What they receive |
|---|---|---|
| utidelone | Experimental | Utidelone Injection: 40 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced or metastatic CRC Receives: Drug: utidelone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response to utidelone treatment
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.
Measured: 6 months from first study treatment
Secondary outcomes (3)
Progression free survival (PFS)
PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator
Measured: 1 year from first study treatment
Overall survival (OS)
OS is defined as the duration of time from first study treatment until death from any cause.
Measured: 2 year from first study treatment
Safety profile associated with utidelone injection
Observe and record adverse effects and severe adverse effects associated with utidelone injection
Measured: 1 year from first study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start12 Apr 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: The efficacy evaluation (based on current data) deviated too much from results of previous clinical trials. It's assumed that high dropout rate of subjects, mainly due to covid-19 epidemic in China in the past 3 years, is the main reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic CRCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Biostar Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- RUIHUA XU, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906565
- Sponsor's protocol ID
- BG01-1811
- Status last verified
- Jan 2023
- First submitted
- 5 Apr 2019
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer After Failure or Intolerability to Second-line Standard Treatment
- ClinicalTrials.gov ID
- NCT03906565
- Acronym / sponsor ID
- BG01-1811
- Conditions
- Advanced or Metastatic CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The efficacy evaluation (based on current data) deviated too much from results of previous clinical trials. It's assumed that high dropout rate of subjects, mainly due to covid-19 epidemic in China in the past 3 years, is the main reason.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Biostar Pharmaceuticals
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic colorectal cancer (CRC) as a phase II trial
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| utidelone | Experimental | Drug: utidelone injectionUtidelone Injection: 40 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced or metastatic CRC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily signed informed consent form; good compliance during the whole study;
- Histologically or cytologically confirmed diagnosis of unresectable advanced or metastatic CRC, not including appendix and anal canal cancer;
- patients failed or intolerable to previous standard second-line treatment for locally advanced or metastatic CRC;
- Patients who have not received previous bevacizumab therapy can be treated in combination with bevacizumab;
- Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy 4 weeks prior to enrollment, with no plan for concurrent other chemotherapy and surgery;
Key exclusion criteria (20 listed)
- Patients having history of other malignancies except CRC within the last five years, but patients with fully recovered in situ cervix carcinoma or non-melanoma skin cancer are eligible;
- No other anticancer therapies, such as chemotherapy, hormonal therapy, immunotherapy, antibody therapy and radiotherapy, or concurrent other chemotherapy during treatment;
- Patients with uncontrollable brain metastasis, uncontrollable bone metastasis or recent risk of fracture;
- Arterial or venous thrombosis or embolic events such as cerebrovascular accident (including TIA), deep venous thrombosis or pulmonary embolism occurred within one year;
- history of symptomatic heart disease (including unstable angina, myocardial infarction and heart failure);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| utidelone injectionAlso: UTD1 injectionutidelone monotherapy in patients with advanced or metastatic CRC by iv transfusing utidelone injection | Drug | utidelone |
Primary outcome
Tumor response to utidelone treatment
Time frame: 6 months from first study treatment
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.
3 secondary outcomes
Progression free survival (PFS)
Time frame: 1 year from first study treatment
Overall survival (OS)
Time frame: 2 year from first study treatment
Safety profile associated with utidelone injection
Time frame: 1 year from first study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUIHUA XU, MD principal investigator
Sun Yat-sen University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing utidelone injection in people with Advanced or Metastatic CRC, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 5 sites in China.
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 20 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: paused, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
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?
Tumor response to utidelone treatment (time frame: 6 months from first study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2023.