EUCTR2020-000138-16-IT进行中（未招募）1 期
A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing theEfficacy and Safety of Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma (ADAGIO) - ADAGIO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Capable of giving signed informed consent and has given signed
- •informed consent as described in Appendix C which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •2. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional
- •genetic research that supports Genomic Initiative.
- •3. Participant must be aged > = 18 years of age inclusive, at the time of signing the informed consent
- •4. Histologically confirmed recurrent or persistent USC. For the purposes of this study, participants with endometrial carcinoma of mixed histology where the serous component comprises at least 10% of the tumour will be considered eligible. Participants with carcinosarcomas are not eligible.
- •5. Evidence of measurable disease as per RECIST v1.1 defined as at least
- •one lesion, not previously irradiated, that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 10 mm with computed tomography (CT) scan or magnetic resonance imaging (MRI) (except lymph nodes which must have short axis = 15 mm) and which is suitable for accurate repeated measurements.
- •6. At least 1 prior platinum-based chemotherapy regimen for the management of USC (there is no restriction on the number of prior lines of systemic therapy that a participant may have previously received, and the platinum-based chemotherapy may have been given in the adjuvant setting). Chemotherapy administered only in conjunction with primary radiotherapy as a radiosensitiser should not count as a systemic regimen.
- •Prior anticancer therapies (IOs, eg, immune checkpoint inhibitors,
- •vascular endothelial growth factor (VEGF) inhibitors and HER2 targeted therapy) are allowed.
- •Participants who have known MSI-H or dMMR tumours will not be eligible unless they have already received prior therapy with pembrolizumab or another PD-1/PD-L1 immune checkpoint inhibitor, in territories where this treatment is available for this indication, or are deemed not to be a candidate for immune checkpoint therapy.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •8. Life expectancy = 12 weeks.
- •9. Participants must have normal organ and marrow function at baseline,
- •as defined below by laboratory values within 7 days prior to study drug(s) administration:
- •- Absolute neutrophil count (ANC) >= 1.5 × 10^9 /L
- •- Haemoglobin (Hb) >= 9 g/dL
- •- Platelet count >= 100 × 10^9 /L
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •>= 3 x upper limit of normal (ULN) or <= 5 x ULN if known hepatic metastases
- •- Serum bilirubin within normal limits (WNL) or <=1.5 x ULN in patients
- •with liver metastases; or total bilirubin = 3.0 x ULN with direct bilirubin
- •WNL in patients with documented Gilbert's Syndrome
- •- Serum creatinine <= 1.5 x ULN, or measured creatinine clearance (CrCl)
- •>= 45 mL/min as estimated using either the Cockcroft-Gault method, a 24-hour urine test or another validated test as per local practice (confirmation of creatinine clearance is only required when creatinine is > 1.5 x institutional ULN).
- •10. Consent to submit and provide a mandatory FFPE tumour sample for
- •central testing. The site must confirm that the FFPE sample is available prior to dosing
- •11. Female patients who are not of childbearing potential and women of
- •childbearing potential who agree to use adequate contraceptive measures from the time of signing the ICF
排除标准
- •1. Any underlying medical condition that would impair the ability of the
- •participant to receive study treatment, as judged by the investigator.
- •2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •3. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade > 1 toxicity from prior therapy (except alopecia, anorexia or CTCAE grade 2 peripheral neuropathy).
- •4. Unable to swallow oral medications
- •5. History of another primary malignancy (exceptions are detailed in Section 5.2 of the Protocol)
- •6. Spinal cord compression or metastases unless asymptomatic, stable,
- •and not requiring steroids for at least 4 weeks prior to start of study intervention.
- •7. Patients with current (or within 28 days prior to Cycle 1, Day 1) signs
- •or symptoms of bowel obstruction, including sub-occlusive disease, related to underlying disease.
- •8. Any of the following cardiac diseases currently or within the last 6
- •- Unstable angina pectoris
- •- Acute myocardial infarction
- •- Congestive heart failure >= Class 2 (as defined by New York Heart
- •Association)
- •- Conduction abnormality not controlled with pacemaker or medication
- •- Significant ventricular or supraventricular arrhythmias (patients with
- •chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
- •9. History of Torsades de pointes unless all risk factors that contributed
- •to Torsades have been corrected.
- •10. a) Resting corrected QTc interval using the Fridericia formula (QTcF) > 480 msec (as calculated per institutional standards) obtained from an
- •electrocardiogram (ECG) (NOTE: if one ECG demonstrates a QTcF > 480 msec, then a mean QTcF of <= 480 msec obtained from 3 ECGs 2-5
- •minutes apart, is required at study entry), or b) congenital long QT syndrome.
- •11. Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- •12. Patients with known active hepatitis (ie, hepatitis B or C):
- •- Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible
- •- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
- •polymerase chain reaction is negative for HCV RNA
- •13. Use of anticancer treatment drug <= 21 days (<= 6 weeks for nitrosoureas or mitomycin C) or use of an investigational product within 5 half-lives prior to the first dose of adavosertib. For PD-1/PD-L1 inhibitors, a minimum of 28 days since last dose is required.
- •Patients on luteinising-hormone releasing hormone analogue treatment
- •for more than 6 months are allowed entry into the study and may continue at the discretion of the investigator.
- •14. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of bone marrow within 4 weeks prior to the first dose of study intervention.
- •15. Major surgical procedures <= 28 days, or minor surgical procedures <=
- •7 days, prior to beginning study treatment. No waiting period required following port-a-cath or other central venous access placement.
- •16. Prior receipt of a cell cycle checkpoint inhibitor (eg, CHK1, WEE1, or ATR inhibition)
研究者
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