EUCTR2017-002026-20-GB进行中（未招募）1 期
A Modular, Multipart, Multiarm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies - A Modular, Multipart, Multiarm, FTiH, Open-label study of CT7001
Carrick Therapeutics0 个研究点目标入组 357 人开始时间: 2017年8月24日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 357
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
- All
入选标准
- •Core Inclusion Criteria:
- •1. At least 18 years of age
- •2. ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks
- •3. Estimated life expectancy of greater than 12 weeks
- •4. Ability to swallow and retain oral medication
- •5. Women of childbearing potential must be willing to practice effective contraception (per protocol definition) for the duration of the study and for 6 months after the last dose of CT7001
- •6. Criteria to identify women not of childbearing potential are defined in the protocol
- •7. Sexually active male subjects must be willing to use contraception per protocol description
- •8. Provision of signed and dated, written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumour tissue.
- •Host Genetics Research Study: Pharmacogenetics Samples (Optional):
- •1. Provision of signed and dated, written informed consent for the genetic research.
- •Module 1A Breast Cancer Cohort additional Inclusion Criteria:
- •1. Histological, radiological or cytological confirmation of breast cancer not considered to be appropriate for further standard treatment.
- •Module 1A Breast Cancer or Solid Tumour Cohort additional Inclusion Criteria:
- •1. At least one tumour suitable for repeat biopsy from the same lesion.
- •Module 1B additional Inclusion Criteria:
- •1. Histological, radiological or cytological confirmation of metastasis or locally advanced tumour not considered to be appropriate for further standard treatment
- •2. At least one line of systemic anti-cancer therapy.
- •3. Disease must be measurable by Response Evaluation Criteria in Solid Tumours (RECIST, version 1.1), per protocol description.
- •Module 1B-1 (TNBC) additional Inclusion Criteria:
- •1. Histologically confirmed carcinoma of the breast not expressing oestrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2), per protocol description
- •2. Metastatic or locally advanced disease not amenable to resection or radiation therapy with curative intent with documented progressive disease on or within 6 months of most recent prior chemotherapy.
- •3. Disease must be measurable by Response Evaluation Criteria in Solid Tumors (RECIST, version 1. 1), per protocol description
- •Module 2 will have standalone eligibility criteria with the principal inclusion defined as below:
- •1. Women 18 years of age or older who are either:
- •o post-menopausal or pre/peri-menopausal. as defined by one of the following criteria:
- •o Pre/peri-menopausal, i.e., not meeting the criteria for being postmenopausal, if amenable to treatment with the LHRH agonist goserelin.
- •5. Histologically confirmed diagnosis of carcinoma of the breast with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
- •6. Documentation of ER-positive and/or PgR-positive tumour based on most recent tumour biopsy utilizing an assay consistent with local standards.
- •7. Documentation of HER2 negativity based on local testing on most recent tumour biopsy.
- •8. Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- •9. Patients must have documented objective disease progression while on or within 6 months after the end of the most recent therapy.
- •10. Patients must have received an aromatase inhibitor together with a CDK4/6 inhibitor in the same line of therapy for the treatment of:
排除标准
- •Core Exclusion Criteria:
- •1. Any other malignancy which has been active or treated within the past 3 years, with the exception per protocol description.
- •2. Any unresolved toxicity (except alopecia) from prior therapy of = Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE).
- •3. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks before the first dose of IP.
- •4. Refractory nausea and vomiting, chronic GI diseases or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of CT7001.
- •5. Uncontrolled seizures.
- •6. Active infection requiring systemic antibiotic, antifungal, or antiviral medication
- •7. Severe or uncontrolled medical condition or psychiatric condition
- •8. Active bleeding diatheses
- •9. Renal transplant
- •10. Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
- •11. Breastfeeding or pregnancy
- •12. Receipt of cytotoxic treatment for the malignancy per protocol description
- •13. Receipt of noncytotoxic treatment for the malignancy within 5 half-lives of the drug before the first dose of IP
- •14. Receipt of corticosteroids per protocol description
- •15. Receipt of any small-molecule investigational medicinal product (IMP) per protocol description
- •16. Receipt of any biological or non-biological anti-cancer medicine per protocol description
- •17. Receipt of St John’s Wort within 21 days before the first dose of IP or of another concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein activity per protocol description
- •18. Receipt of a blood transfusion (blood or blood products) per protocol description
- •19. Known hypersensitivity to CT7001 or any excipient of the product
- •20. Impaired hepatic or renal function
- •21. Liver function deteriorating in a manner per protocol description
- •22. Other evidence of impaired hepatic synthesis function
- •23. Inadequate bone marrow reserve or organ function
- •24. Persistent severe pancytopenia due to previous therapy rather than to disease
- •25. Cardiac dysfunction
- •26. Mean resting QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec
- •27. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG. Controlled atrial fibrillation (AF) is permitted
- •28. Any factor that increases the risk of QTc prolongation or of arrhythmic events (e.g. per protocol description)
- •29. In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements
- •30. A history of haemolytic anaemia or marrow aplasia
- •31. Has received a live-virus vaccination within 28 days or less of planned treatment start.
- •Host Genetics Research Study: Pharmacogenetics Samples (Optional), Exclusion Criteria
- •1. Allogenic bone marrow transplant.
- •2. Non-leucocyte-depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
- •Additional Exclusion Criteria (Module 1 Part A)
- •International normalised ratio (INR) = 1.5.
- •Module 1B: No additional exclusion criteria to core.
- •Module 1B-1 (TNBC) additional Exclusion Criteria:
- •1. More than three lines of chemotherapy for metastatic and/or locally advanced disease.
- •2. Advanced, symptomatic, visceral metastases if risk of life-threatening complications in the short term
- •1. Prior therapy with fu
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