Myeloprotection With Trilaciclib in Pan-cancer Population

Launched by SUN YAT-SEN UNIVERSITY · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called trilaciclib to see if it can help protect the bone marrow in patients with various types of cancer, including non-small cell lung cancer, breast cancer, endometrial cancer, cervical cancer, and head and neck cancers. The trial will compare two groups: one group will receive trilaciclib along with standard chemotherapy (paclitaxel and carboplatin), while the other group will receive only the chemotherapy. Researchers want to find out if trilaciclib is safe and effective in helping patients manage side effects during treatment.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of advanced or recurrent cancer. They should also have good overall health and meet specific criteria related to their blood and organ function. Participants can expect to receive chemotherapy for at least six cycles and may have the option to continue treatment depending on their progress and response to therapy. This study is not yet recruiting, so there will be more information available in the future about how patients can join.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years;
• • 2. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
• 3. Histologically or cytologically confirmed advanced or recurrent solid malignant tumors, including:
• • Unresectable stage III/IV non-small cell lung cancer (NSCLC);
• • Recurrent or metastatic breast cancer (BC);
• • Newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IC-IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer without further surgical planning before disease progression; or recurrent platinum-sensitive ovarian cancer (OC);
• • FIGO stage III-IV or recurrent endometrial cancer (EC), including endometrioid carcinoma and serous or clear cell carcinoma;
• • FIGO stage IVB (including persistent) or recurrent cervical cancer (CC) (≤ 1 prior platinum-based therapy) not amenable to radical surgery or radiotherapy;
• • Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (including primary lesions located in the larynx, oropharynx, hypopharynx, oral cavity, undifferentiated or poorly differentiated nasopharyngeal carcinoma, and salivary gland carcinoma), which is not suitable for further surgery or radiotherapy.
• • 4. At least one measurable lesion according to RECIST version 1.1;
• • 5. Received up to one prior systemic chemotherapy and no prior paclitaxel plus carboplatin chemotherapy;
• • 6. Adequate organ function meeting the following criteria: (1) adequate bone marrow function: Hb ≥ 100 g/L (no ESA or blood transfusion within 14 days before the first dose); ANC ≥ 2 × 10\^9/L (no G-CSF within 14 days before the first dose); platelet count ≥ 100 × 10\^9/L (no rhTPO, rhIL-11 or platelet transfusion within 14 days before the first dose); (2) adequate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); (3) adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%;
• • 7. Life expectancy ≥ 3 months;
• • 8. Females of childbearing potential agree to practice reliable contraception during the clinical trial and have a negative serum or urine pregnancy test within 7 days prior to dosing;
• • 9. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
• Exclusion Criteria:
• • 1. History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease;
• • 2. Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiation or steroid therapy;
• • 3. Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug;
• • 4. Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug;
• • 5. Platinum-resistant OC (refractory to 1 line of platinum-based chemotherapy or recurrent platinum-based chemotherapy within 6 months prior to the first dose of study drug);
• • 6. Requires concurrent radiotherapy;
• • 7. Known history of hypersensitivity to the drug components of this protocol;
• • 8. Pregnant or lactating women;
• • 9. Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.