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Myeloprotection With Trilaciclib in Pan-cancer Population

NCT06297811 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-03-07

No results posted yet for this study

Summary

The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:

* effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy
* does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type

Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.

Conditions

Interventions

DRUG

Trilaciclib Injection

Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection \[Cosela\] 240 mg/m\^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

DRUG

Paclitaxel

Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.

DRUG

Carboplatin

area under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297811 on ClinicalTrials.gov