Trials / Not Yet Recruiting
Not Yet RecruitingNCT06297811
Myeloprotection With Trilaciclib in Pan-cancer Population
Efficacy and Safety of Trilaciclib in Myeloprotection During Chemotherapy for Advanced/Recurrent Malignant Solid Tumors - A Phase II Study
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Non-Small Cell Lung Cancer
- Breast Cancer
- Endometrial Cancer
- Cervical Cancer
- Head And Neck Squamous Cell Carcinomas
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2025-09-30
- Completion
- 2027-12-31
- First posted
- 2024-03-07
- Last updated
- 2024-03-07
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06297811. Inclusion in this directory is not an endorsement.