AzTrials
AzTrials

Gastric Cancer Adenocarcinoma MetastaticPhase 2NCT06730581

Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors

A Phase 2 study testing Utidelone Capsule 60mg/m2/d, Utidelone capsule 75mg/m2 and Utidelone Capsule in people with Gastric Cancer Adenocarcinoma Metastatic and Ovarian Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Utidelone Capsule 60mg/m2/d, Utidelone capsule 75mg/m2 and Utidelone Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Dec 2024to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • -
  • 1、 For participants with advanced gastric cancer:Histologically and/or cytologically confirmed unresectable HER2-negative locally advanced or recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma (according to the 2019 WHO Classification of Digestive System Oncology).
  • 2、 For participants with advanced cholangiocarcinoma:Histologically and/or cytologically, patients were diagnosed with surgically unresectable advanced or metastatic cholangiocarcinoma.
  • 3、 For participants with advanced ovarian cancer:A histologically or pathologically confirmed diagnosis of high-grade serous ovarian cancer was consistent with platinum-resistant recurrent ovarian cancer (progression within 6 months after the last platinum-based chemotherapy) according to the 2020 WHO histopathological classification of ovarian tumors.
  • 4、 For participants with other tumors:
  • Esophageal cancer: locally advanced recurrent or metastatic squamous esophageal cancer confirmed by histology or cytology.
Show all 21Show fewer
  • Hepatocellular carcinoma: clinically diagnosed or histologically/cytologically confirmed diagnosis of inoperable resectable or metastatic hepatocellular carcinoma (HCC) (according to the Guidelines for the Management of Primary Hepatocellular Carcinoma (2024 edition)); Child-Pugh score ≤ 7.
  • Colorectal cancer: unresectable advanced/metastatic colorectal cancer (mCRC) confirmed by histology or cytology.
  • Recurrent or metastatic cervical cancer confirmed by histopathology, not amenable to radical surgical resection and/or radical radiotherapy, and pathologic type of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
  • 5、For all participants:
  • Subjects must give informed consent to the study prior to the study, and voluntarily sign a written informed consent form (ICF), understanding and agreeing to comply with the study requirements and test procedures;
  • ≥18 years old and ≤70 years old;
  • According to RECIST v1.1, patients had at least one target lesion (non-radiotherapy field) that could be measured by computed tomography (CT) or magnetic resonance imaging (MRI) (longest diameter ≥10mm, lymph node diameter ≥15mm, scan layer thickness ≤ 5mm).
  • Have received at least one standard systemic therapy, and the number of previous systemic anti-tumor therapy lines is ≤4 (neoadjuvant and adjuvant chemotherapy regiments are not considered prior systemic therapy unless disease progression occurs during their chemotherapy or within 6 months after the last chemotherapy);
  • The blood routine examination within 1 week before enrollment was basically normal (the normal value of the laboratory of each research center was the standard); No rhG-CSF, blood transfusion /EPO and other drugs were used within 14 days before enrollment.
  • White blood cell count (WBC) ≥3.5 × 109/L b.Neutrophil count (ANC) ≥ 1.5 × 109/L; c.Platelet count (PLT) ≥ 100 × 109/L; d.Hemoglobin ≥ 9.0 g/dL.
  • Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory):
  • a.Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) b.SGPT/ALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); c.SGOT/AST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); d.The creatinine clearance rate (Ccr) is ≥ 60 ml/min (Cockcroft Gault formula).
  • adequate coagulation function, defined as INR or PT ≤1.5 times ULN; If the subject was receiving anticoagulant therapy, as long as the PT was within the prescribed range of anticoagulant drugs.
  • ECOG 0-1 with an expected survival of more than 12 weeks;
  • Patients of childbearing potential had to consent to use a reliable contraceptive method (hormonal or barrier methods or abstinence) with their partner simultaneously during the trial and for at least 3 months after the last dose; Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.

Who cannot join

  • -
  • 1、 For participants with advanced gastric cancer:Patients with HER2-positive disease.
  • 2、 For participants with advanced ovarian cancer: 1) Having a clear cell, mucinous or sarcomatous histology, containing mixed tumours of any histological type, or low grade/borderline ovarian cancer; 2) Platinum-refractory ovarian cancer: tumor progression assessed within 1 month after the last dose of platinum therapy.
  • 3、 For all participants:
  • Other malignancies within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid;
  • Received nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug; Anti-tumor therapy, including chemotherapy, radiotherapy, biotargeted therapy, immunotherapy, etc. within 4 weeks or 5 half-lives (whichever is shorter) prior to the first use of the investigational drug; Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is shorter; Use of traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first use of the investigational drug.
Show all 30Show fewer
  • had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period.
  • Patients with peripheral neuropathy CTCAE 5.0 grade ≥2.
  • The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).
  • Patients who had previously used Utidelone injection.
  • Patients with gastrointestinal bleeding, active gastrointestinal ulcers or gastrointestinal obstruction (including paralytic ileus), gastrointestinal perforation or fistula, and intraperitoneal abscesses within 6 months prior to the first use of the investigational drug;
  • Patients with dysphagia, or other factors that affect the oral administration and absorption of drugs, or who require parenteral nutrition;
  • Clinically active brain metastases, spinal cord compression, or spread of pia meningioma, defined as symptomatic or requiring steroid hormone or anticonvulsant therapy to control related symptoms; Patients with confirmed progression of brain metastases within 2 months after radiotherapy or other local treatment;
  • Clinically severe lung injury caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc., with clinical symptoms requiring intervention within 3 months prior to the first use of the investigational drug);
  • Patients with clinical symptoms of cancerous ascites, pleural effusion and pericardial effusion requiring puncture and drainage; Or had undergone drainage of ascites, pleural effusion, or pericardial effusion within 30 days prior to the first use of the study drug.
  • Imaging shows that the tumor has invaded the vicinity of important blood vessels or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding;
  • Have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:
  • Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree Ⅱ-Ⅲ atrioventricular block, etc.; At rest, QTcF> 450 ms in men or 470ms in women was examined by 12-lead electrocardiogram (Fredericia's formula, see Appendix IV);
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to first use of the study drug;
  • Clinically uncontrollable hypertension;
  • Other researchers have identified a high risk of heart disease.
  • Patients with uncontrolled diabetes within 3 months prior to first use of the study drug.
  • Patients with active hepatitis B and/or hepatitis C, i.e. HBsAg positive and/or HBcAb positive with HBV DNA positive and/or anti-HCV positive and HCV RNA positive; Positive for human immunodeficiency virus (HIV) antibodies; The specific antibody of treponema pallidum was positive.
  • Those who have an active infection and currently require systemic anti-infective therapy.
  • Had an active autoimmune disease that required systemic treatment (i.e., disease modulators, corticosteroids, or immunosuppressive drugs) within 2 years prior to enrollment. Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.
  • Women who are pregnant or nursing or plan to become pregnant during the study period.
  • Patients with mental disorders or poor compliance.
  • Known allergy to the investigational drug or any of its excipients.
  • Concurrent participation in another interventional clinical trial or use of another investigational treatment.
  • The researchers believe that the subjects have a history of serious systemic disease, or other reasons should not be enrolled in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

RONGGUO QIU PhD contact

010-56315388

Rqiu2001@yahoo.com

Ruihua Xu Study Principal Investigator contact

About this study

Official title: Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients

This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.

Being tested
Utidelone Capsule 60mg/m2/d, Utidelone capsule 75mg/m2, Utidelone Capsule
Keywords
Gastric Cancer, Ovarian Cancer, bile duct cancer
Medical subject headings
Ovarian Neoplasms, Bile Duct Neoplasms, Stomach Neoplasms

What participants receive

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

  • Utidelone Capsule 60mg/m2/dDrug

    60mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

  • Utidelone capsule 75mg/m2Drug

    75mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

  • Utidelone CapsuleDrug

    Dosing regimens were determined based on the results of gastric and ovarian cancer dosing regimens.D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Study groups in NCT06730581
Study groupRoleWhat they receive
Gastric cancer groupExperimentalNot described
Receives: Drug: Utidelone Capsule 60mg/m2/d
Ovarian and cholangiocarcinoma groupsExperimentalNot described
Receives: Drug: Utidelone capsule 75mg/m2
Other oncology indications (including esophageal cancer, liver cancer, colorectal cancer, cervical cExperimentalNot described
Receives: Drug: Utidelone Capsule

What is being measured

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

  1. Objective Response Rate （ORR）according to the RECIST 1.1.

    Measured: 18 months

Secondary outcomes (8)

  1. Progression-Free Survival, PFS

    Measured: 18 months

  2. Clinical Benefit Rate （CBR）according to the RECIST 1.1.

    Measured: 18 months

  3. CA125 versus baseline remission rate, only the ovarian cancer group was eligible

    Measured: 18 months

  4. Maximum (or peak) serum concentration-Cmax

    Measured: 18 months

  5. Time to peak drug concentration-Tmax

    Measured: 18 months

  6. The area under the concentration-time curve from dosing (time 0) to time t-AUC0-t

    Measured: 18 months

  7. The time required for plasma concentration of a drug to decrease by 50%-t1/2

    Measured: 18 months

  8. Treatment-related Adverse Event-TRAE

    Measured: Until 28 days after the last dose of treatment

Timeline

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

  1. First posted12 Dec 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730581
Sponsor's protocol ID
BG02-2403
Status last verified
Nov 2024
First submitted
21 Nov 2024
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Utidelone Capsule 60mg/m2/d, Utidelone capsule 75mg/m2 and Utidelone Capsule in people with Gastric Cancer Adenocarcinoma Metastatic and Ovarian Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd..

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 21 inclusion and 30 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: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact RONGGUO QIU PhD (010-56315388, Rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate （ORR）according to the RECIST 1.1. (time frame: 18 months). 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 NCT06730581.

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 Dec 2024.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in