Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.

NCT04778839 | Recruiting Phase 1

• 1 other identifier: HZDH20-002
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Breast cancer; ovarian cancer; non-small cell lung cancer; gastric cancer; Paclitaxel Micelles

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of Paclitaxel Micelles for Injection in dose ascending and dose extension as measured by assessment of maximum tolerated dose (MTD) and dose limiting toxicity (DLT).

  MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT

  2 years

• The recommended dose for the phase II study

  Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups

  2 years

Secondary Outcomes (13)

• Cmax of Paclitaxel Micelles for Injection

  Cycles 1(each cycle is 21 days) ,Day1 to Day4.

• Tmax of Paclitaxel Micelles for Injection

  Cycles 1(each cycle is 21 days) ,Day1 to Day4.

• AUC0-t of Paclitaxel Micelles for Injection

  Cycles 1(each cycle is 21 days), Day1 to Day4.

• AUC0-inf of Paclitaxel Micelles for Injection

  Cycles 1(each cycle is 21 days) ,Day1 to Day4.

• λz of Paclitaxel Micelles for Injection

  Cycles 1(each cycle is 21 days), Day1 to Day4.

Study Arms (2)

Paclitaxel Micelles for Injection

EXPERIMENTAL

In the First Period, Only three Participants in the first dose group were randomly assigned to 175 mg/m2 paclitaxel micelle for injection at a 1:1 rate.175 mg/m2, 260 mg/m2, 320 mg/m2, and 390 mg/m2 of paclitaxel micelle for Injection was intravenously administrated for three hours,three weeks constituted one course of treatment.

Drug: Paclitaxel Micelles for Injection

Paclitaxel Injection

ACTIVE COMPARATOR

three Participants were randomly assigned to 175 mg/m2 paclitaxel Injection,175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

Drug: Paclitaxel injection

Interventions

Paclitaxel Micelles for Injection DRUG

Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

Paclitaxel Micelles for Injection

Paclitaxel injection DRUG

Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.

Paclitaxel Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 recovery from previous surgery within 4 weeks prior to enrollment, and no surgical operation was planned during the study period.
• 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 prior to the screening phase laboratory examination):Hb≥90g/L , ANC≥1.5×109/L , PLT≥100×109/L.
• 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); TBIL(Total bilirubin)≤1.5×ULN; creatinine≤1.5×ULN and CL≥ 60 mL/min\[The calculation formula was as follows: CCR (140- age)× body weight (kg) /0.818× SCR (μmol/L), and female was calculated as ×0.85\].
• 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 condoms）.Women of child-bearing age must be negative for serum HCG within 14 days prior to study enrolment and must be non-lactating。
• 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.

You may not qualify if:

• 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 subjects or affects their completion of the test(such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, etc).
• 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, cyclosporine, teniposide, etoposide, vincrine, testosterone, 17-α diethylstilbestrol, retinoic acid, quercetin, etc).
• 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 patients with history of uncontrollable hypertension, arrhythmias considered clinically significant by the investigator, or electrocardiogram (ECG) abnormalities.
• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Hangzhou Dihua Biotechnology Co., LTD.: collaborator

Study Sites (1)

The First Affiliated Hospital,ZheJiang Univercity

Hanzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms

Interventions

Injections; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• jian liu, master

  The First Affiliated Hospital,ZheJiang Univercity

  PRINCIPAL INVESTIGATOR

• xiaochen zhang, docter

  The First Affiliated Hospital,ZheJiang Univercity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jian liu, master

CONTACT

+86-13958054006; lindaliu87@zju.edu.com

xiaochen zhang, docter

CONTACT

+86-13957169922; zhangxiaochen74@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 3, 2021
• Study Start: March 4, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)