NL-OMON51947已完成2 期
An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination, in patients with advanced solid/metastatic tumours. - Phase I/IIa study to evaluate CCS1477 in advanced tumours
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Written informed consent;
- •2. willing and and able to comply with study protocol procedures
- •3. >= 18 years
- •4. ECOG performance status 0-1 with no deterioration over previous 2 weeks and
- •minimum life expectancy of 12 weeks
- •5. Adequate organ functions:
- •AST/ALT <=3 x ULN or AST/ALT <=5 x ULN
- •Total bilirubin <=1.5 x ULN (or <3 UNL if bilirubin rise is due to Gilbert's
- •syndrome or of non-hepatic origin, or due to underlying liver involvement).
- •Calculated creatinine clearance by Cockcroft-Gault formula >=30 ml/min²
- •ANC >=1.5 x 109/L
- •Platelets >=100 x 109/L
- •Haemoglobin >=9g/dL. (maintained without transfusion within 14 days of
- •starting CCS1477)
- •Normal sodium level (patients with borderline sodium decrease below normal
- •level may be eligible following discussion with medical monitor).
- •Serum albumin >2.5 g/dL
- •LDH within normal level (patients with borderline LDH results may be eligible
- •following discussion with medical monitor)
- •6. For duration of the study and 1 week after the last study administration,
- •sexually active male patients must be willing to use barrier contraception with
- •all sexual partners. Where the sexual partner is a *woman of child-bearing
- •potential* who is not using effective contraception, men must use a condom and
- •another form of contraception during the study and for 6 months after the last
- •dose of study medication.
- •7. Females must agree to use highly effective contraceptive measures, must not
- •be breast feeding and must have a negative serum pregnancy test prior to start
- •of dosing if of child-bearing potential, or must have evidence of
- •non-child-bearing potential at screening per one of:
- •Post menopausal defined as aged more than 50 years and amenorrhoeic for at
- •least 12 months following cessation of all exogenous hormonal treatments
- •Documentation of irreversible surgical sterilisation by hysterectomy,
- •bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- •Amenorrhoeic for 12 months and serum FSH, LH and plasma oestradiol levels in
- •the postmenopausal range for institution
- •8. Patients must have assessable disease (by CT, MRI, bone scan or X-ray) but
- •are not required to have measurable disease
- •Additional inclusion criteria for mCRPC patients (Parts A, B, C, D and F only)
- •9. Patients must have previously received standard available therapy including
- •(but not limited to):
- •abiraterone and/or enzalutamide (or equivalent anti-androgen), and
- •a taxane (unless ineligible)
- •10. Progressive disease documented by one or more of:
- •Biochemical progression defined as at least 2 stepwise increases in a series
- •of any 3 PSA values collected while the patient has castrate levels of
- •testosterone. The 3 PSA values selected do not need to be consecutive, and do
- •not need to include the most recent PSA collected at, or prior to, study
- •enrolment, but must meet the following criteria:
- •a. PSA progression defined by minimum of 3 rising PSA levels with an interval
- •of >=1 week between each determination
- 另有 5 项未显示
排除标准
- •All Patients:
- •1. Intervention with any of the following
- •Any chemotherapy, investigational agents or other anti-cancer drugs within 14
- •days or 5 half-lives (whichever is longer of these two) of the first dose of
- •study treatment (excludes treatment with immunotherapy agents which must be
- •assessed on a case by case basis). This does not apply to prior treatment with
- •abiraterone for patients in Part C1 or C2 or prior treatment with enzalutamide
- •for patients in Part D1 (except patients in the DDI arm who must have a 4 week
- •washout of enzalutamide prior to starting the study) and D2.
- •Radiotherapy with a wide field of radiation or to more than 30% of the bone
- •marrow within 4 weeks of the first dose of study treatment
- •Major surgical procedure or significant traumatic injury as judged by the
- •investigator, within 4 weeks of the first dose of study treatment, or have an
- •anticipated need for major surgery during the study
- •Strong inducers of CYP3A4 (See Appendix E) taken within 4 weeks of the first
- •dose of study treatment or while on study treatment (excluding enzalutamide in
- •Part D1 and D2 which does not require a 4 week wash-out prior to the first dose
- •of study treatment, except for patients in the DDI arm).
- •Strong inhibitors of CYP3A4 or CYP2C8 or CYP3A4 sensitive substrates (See
- •Appendix E) taken within 2 weeks of the first dose of study treatment or while
- •on study treatment.
- •Washout periods may be reduced for specific medications (eg. statins)
- •following discussion with the medical monitor.
- •Herbal medications cannot be taken within 7 days of the first dose of study
- •treatment (4 weeks for St John*s wort) or while on study treatment
- •Statins; patients may receive fluvastatin or pravastatin (with monitoring for
- •potential toxicities), or atorvastatin or simvastatin at 10mg daily dose only.
- •Systemic cancer treatment should not be initiated for at least 30 days after
- •the last administration of Radium-223 (Ra-223, Xofigo)
- •2. Any unresolved reversible toxicities from prior therapy greater than Common
- •Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting
- •study treatment with the exception of alopecia and neuropathy
- •3. Female patients who are pregnant or breast-feeding at study entry. Breast
- •feeding is contraindicated during study treatment and for 1 month after study
- •drug is discontinued.
- •4. Any evidence of severe or uncontrolled systemic diseases, including for
- •example diabetes, uncontrolled hypertension and active bleeding diatheses,
- •which in the investigator*s opinion makes it undesirable for the patient to
- •participate in the study or which would jeopardise compliance with the
- •protocol, or active infection* including hepatitis B, hepatitis C and human
- •immunodeficiency virus (HIV). *Active viral infection is defined as requiring
- •antiviral therapy. Screening for chronic conditions is not required
- •5. Patients with any known uncontrolled inter-current illness including ongoing
- •or active clinically significant infections, symptomatic congestive heart
- •failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or
- •psychiatric illness/social situations that would limit compliance with study
- •requirements. Refractory nausea and vomiting, chronic gastrointestinal diseases
- •or previous significant bowel resection, with clinica
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