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OncoMatch/Clinical Trials/NCT04778839

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

Is NCT04778839 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Paclitaxel and Paclitaxel Micelles for for advanced solid tumors.

Phase 1RecruitingFirst Affiliated Hospital of Zhejiang UniversityNCT04778839Data as of May 2026

Treatment: Paclitaxel · Paclitaxel Micelles forA 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: paclitaxel

Exception: unless not resistant

Patients who had been treated with paclitaxel and were determined by the researchers to be resistant

Lab requirements

Blood counts

Hb ≥ 90 g/L, ANC ≥ 1.5×10^9/L, PLT ≥ 100×10^9/L; no blood transfusion, blood products, or hematopoietic growth factors within 14 days prior to screening

Kidney function

creatinine ≤ 1.5×ULN and CL ≥ 60 mL/min

Liver function

ALT or AST ≤ 2.5×ULN (for patients with hepatic metastases, ALT or AST ≤ 5 × ULN); TBIL ≤ 1.5×ULN

Cardiac function

LVEF ≥ 50%

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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