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New treatment option for Advanced Solid Tumors
Official title Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT04778839
What this study is testing
What is Paclitaxel Micelles for Injection?
Paclitaxel Micelles for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants are required to meet all the criteria below in order to be included in the trial:
- Confirmed diagnosis of advanced solid tumors by histological or cytological examination, participants have no effective standard anticancer therapy...
- Male or female patient, aged 18 \~ 70 years.
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
You likely can't join if
- Eligible participants must not meet any of the following exclusion criteria:
- Patients with the toxicity of previous antitumor therapy did not return to grade 1 or below (CTCAE 5.0 grade \>1, excluding toxicity such as alopecia...
- Patients with (including suspected) an allergic history to Paclitaxel, or any of its components, or allergic constitution (excluding mild...
- Patients with bleeding tendency or who are receiving thrombolytic or anticoagulant therapy.
- Patients who had been treated with paclitaxel and were determined by the researchers to be resistant.
- Patients with active central nervous system metastases,But patients with BMs who have received prior treatment and the metastases were stable can...
See the full eligibility criteria
Who can join
- Participants are required to meet all the criteria below in order to be included in the trial:
- Confirmed diagnosis of advanced solid tumors by histological or cytological examination, participants have no effective standard anticancer therapy available or is failed to standard anticancer therapy.
- Male or female patient, aged 18 \~ 70 years.
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Participants with at least 1 measurable tumor lesion and/or assessable non-measurable lesion based on RECIST 1.1.
- No radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy (such as experimental drugs, biological agents, Chinese herbal medicine, etc.), surgical treatment (except diagnostic biopsy), or complete...
- No severe hematopoietic abnormalities(no blood transfusion, no blood products, no granulocyte colony-stimulating factor, platelet stimulating factor, or other hematopoietic growth factors were corrected within 14 days...
- No serious organic disease of heart, liver or kidney:LVEF≥50% ; ALT(Alanine aminotransferase) or AST(Aspartate transaminase)≤2.5×upper limit of normal(ULN)(for patients with hepatic metastases, ALT or AST≤5 × ULN)...
- The coagulation function is normal:PT、APTT and INR≤1.5×ULN。
- Participants (including partners) who are willing to follow reliable contraceptive measures during the study and until 3 months after the last dosing（such as intrauterine devices [IUDs], birth control pills or...
- Participants with voluntarily signature Informed Consent Form (ICF) before the test, and have a full understanding of the test content, process and possible adverse reactions.
- Participants with good compliance, were available for follow-up, and volunteered to comply with study regulations.
What rules you out
- Eligible participants must not meet any of the following exclusion criteria:
- Patients with the toxicity of previous antitumor therapy did not return to grade 1 or below (CTCAE 5.0 grade \>1, excluding toxicity such as alopecia and other toxicity judged by investigators to be of no safety risk).
- Patients with (including suspected) an allergic history to Paclitaxel, or any of its components, or allergic constitution (excluding mild asymptomatic seasonal allergy).
- Patients with bleeding tendency or who are receiving thrombolytic or anticoagulant therapy.
- Patients who had been treated with paclitaxel and were determined by the researchers to be resistant.
- Patients with active central nervous system metastases,But patients with BMs who have received prior treatment and the metastases were stable can participate in the study.
- Patients with cerebrovascular accident or transient ischemic attack in the previous 6 months were screened.
- People with active infection and need anti-infection or antiviral treatment.
- Patients have suffered from other malignant cancers within 5 years (except for cured basal cell carcinoma and cervical carcinoma in situ).
- Concomitant diseases, as determined by the investigator, that seriously endangers the safety of people or affects their completion of the test(such as gastrointestinal bleeding, intestinal obstruction, intestinal...
- Patients with a clear history of neurological or psychiatric disorders (including epilepsy and dementia).
- Patients who have used any drugs that is CYP2C8 and/or CYP3A4 inducer or inhibitor Within 30 days before use of the test drug(including ketoconazole and other imidazole antifungal agents, verapamil, diazepam, quinidine...
- Patients who received blood transfusion and transfusion of blood products, such as albumin, within 2 weeks prior to trial.
- Patients with peripheral neuropathy above grade II.
- Patients with history of myocardial infarction(within 6 months prior to enrollment) ,severe or unstable angina, coronary or peripheral artery bypass grafting or congestive heart-failure (CHF) at NYHA 3-4 level ;and...
- HIV infection, or active HBV infection (HBsAg and/or HBcAb positive, with peripheral blood HBV DNA ≥1 x 103 IU/ mL), or active HCV infection (HCV antibody positive, HCV RNA≥500 IU/ mL).
- Alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol,such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine)within 2 weeks before screening, or patients with drug...
- Patients who participated in other study within the last 1 month.
- Pregnant or nursing women.
- Patients who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.