Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT04520269
Eligibility Criteria:
Inclusion Criteria:
Patients may be included in the study only if they meet all of the following criteria:
* Age \> or = 21 years.
* Histological or cytological diagnosis of malignant advanced solid tumors refractory to standard therapy or for which no suitable effective standard therapy exists.
o Patients who fit above criteria will be pre-screened for presence of 1q21.3 amplification using a plasma assay based on digital PCR. Patients with tumors that exhibit 1q21.3amplification will be enrolled. Positive 1q21.3 amplification is defined as more than 3 standard deviations above the mean comparing the averaged copy number ratio of 3 genes (TUFT1, S100A8 and S100A7) relative to the reference gene RPP30 measure in sample (13).
* ECOG 0-2
* Has measureable or evaluable disease based on RECIST 1.1 criteria
* Estimated life expectancy of at least 12 weeks.
* Has documented progressive disease from last line of therapy
* Has recovered from acute toxicities from prior anti-cancer therapies
* Adequate organ function including the following:
* Bone marrow:
* Absolute neutrophil (segmented and bands) count (ANC) \> or = 1.5 x 109/L
* Platelets \> or = 100 x 109/L
* Hemoglobin \> or = 8 x 109/L
* Hepatic:
* Bilirubin \< or = 1.5 x upper limit of normal (ULN),
* ALT or AST \< or = 2.5x ULN, (or \< or = 5 X with liver metastases)
* Renal:
* Creatinine \< or = 1.5x ULN
* Signed informed consent from patient
* Able to comply with study-related procedures.
* Prior therapy (patients enrolled in phase Ib may be enrolled if they fulfil prior therapy criteria for either Cohort A or Cohort B)
* Cohort A only: Has received at least 2 lines of systemic therapy (endocrine or chemotherapy) in the palliative setting. Chemotherapy in an adjuvant setting for which patients relapsed within 6 months of completion can be considered as line(s) of palliative therapy.
* Cohort B only: Any number of prior lines of palliative chemotherapy.
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
* Treatment within the last 30 days with any investigational drug.
* Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Major surgery within 28 days of study drug administration.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Significant recent bleeding history defined as CTCAE grade 2 or higher within the past 3 months, unless precipitated by an inciting event (e.g. surgery, trauma, injury).
* Suboptimal cardiac function, defined by:
* Any history of CTCAE grade \> or = 2 non-dysrhythmia cardiac conditions within the last 6 months
* New York Heart Association class II, III or IV congestive cardiac failure
* Left ventricular ejection fraction of \<45%
* QTc prolongation of \>450ms as assessed by ECG or other factors that increase the risk of QT interval prolongation
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Symptomatic brain metastasis.
* History of significant neurological or mental disorder, including seizures or dementia.
* Unable to comply with study procedures
* Systemic treatment with a strong CYP3A4 inhibitor or storn CYP450 inducer within 14 days prior to treatment Day 1
Phase Ib lead-in can recruit patients who fulfil critieria for either Cohort A or Cohort B AND all other inclusion/exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT04520269
Study Brief:
Protocol Section:
NCT04520269