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Clinical trial’s patient recruitment status
Phase of the clinical trial that is recruiting (I, II, or III)
A flag to indicate whether the trial is an immunotherapy trial
Prior Immunotherapy Allowed
Whether the clinical trial is open to patients who have received prior immunotherapy
A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Therapeutics used in the clinical trial
Selected Inclusion Criteria:
Age ≥ 18 years of age at the time of signing the informed consent. Patients > 70 years of age must have a G8 Health State Screening Tool (geriatric screening tool) score >.
Proficient mismatch repair/microsatellite stable (pMMR/MSS), histologically or cytologically-confirmed adenocarcinoma of the colon or rectum. Patients with any BRAF or KRAS mutation status are eligible.
Unresectable and measurable or evaluable disease per RECIST v1.1
ECOG performance status of 0 to 1
A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting pMMR/MSS mCRC must be confirmed to be available to send to the Sponsor for planned retrospective biomarker analyses.
Adequate organ function
Prior systemic therapy for mCRC. Patients who received adjuvant/neoadjuvant therapy (ie, treatment with curative intent) for colorectal cancer are eligible if it has been ≥ 6 months between the last dose of systemic chemotherapy and the date of informed consent.
Any radiotherapy, chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or PSA persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.
Receipt of any low-dose systemic chemotherapeutic agent (e.g., low-dose methotrexate for rheumatoid arthritis) administered for a nononcologic purpose within 3 weeks prior to the first dose of trilaciclib/placebo.
Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
QTcF interval > 450 msec (males) or > 470 msec (females) at screening. For patients with ventricular pacemakers, QTcF > 500 msec.
Personal or family history of long QT syndrome
Symptomatic peripheral neuropathy
History of interstitial lung disease (ILD)
Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation
Trial ID number from clinicaltrials.gov or other database
Date Trial Added
Date on which the clinical trial was added to the clinicaltrials.gov website
Date on which the clinical trial was updated on the clinicaltrials.gov website
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