NL-OMON53340招募中2 期
Phase I/II study with galunisertib combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer with peritoneal metastases - Galunisertib combined with capecitabine in advanced CRC with PM
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 31 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
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 99（—）
入选标准
- •1. Histological or cytological proof of CRC with at least confirmed peritoneal
- •metastases (presence of additional extraperitoneal metastases is allowed);
- •2. Disease progression or relapse upon treatment for advanced CRC with
- •fluoropyrimidine containing chemotherapy as single agent or in combination with
- •other anti-cancer drugs, with no treatment options at time of inclusion
- •(combinations with oxaliplatin, irinotecan, bevacizumab and
- •cetuximab/panitumumab are allowed);
- •3. Age >= 18 years;
- •4. Able and willing to give written informed consent and informed consent form
- •must have been signed before start of the trial;
- •5. WHO performance status of <=1;
- •6. Able and willing to undergo blood sampling for PK analysis;
- •7. Able and willing to undergo tumor biopsy before start, during treatment and
- •at the end of treatment;
- •8. Life expectancy > 3 months allowing adequate follow up of toxicity and
- •anti-tumor activity;
- •9. Evaluable disease according to RECIST 1.1 criteria (measurable disease for
- •the phase II part; evaluable disease is sufficient for the phase I part);
- •10. Minimal acceptable safety laboratory values
- •a. ANC of >=1.5 x 109 /L
- •b. Platelet count of >=100 x 109 /L
- •c. Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ALAT and ASAT <=
- •3.0 x ULN, or ALAT and ASAT < 5 x ULN in patients with liver metastases
- •d. Renal function as defined by serum creatinine <= 1.5 x ULN
- •e. Creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula or MDRD);
- •11. Negative pregnancy test (urine or serum) for female patients with
- •childbearing poten-tial.
- •12. Able and willing to swallow tablets.
排除标准
- •1. Any treatment with investigational drugs within 30 days prior to receiving
- •the first dose of investigational treatment and/or radio- or chemotherapy
- •within the last 2 weeks prior to receiving the first dose of investigational
- •treatment. Palliative radia-tion (1x 8Gy) is allowed; except radiotherapy
- •focused on the liver;
- •2. Known or suspected complete or partial dihydropyrimidine dehydrogenase
- •deficien-cy (Mutant for DPD*2A genotype, 1236G>A genotype, 1679T>G genotype and
- •2846A>T genotype);
- •3. Symptomatic or untreated leptomeningeal disease;
- •4. Symptomatic brain metastasis. Patients previously treated or untreated for
- •these conditions that are asymptomatic in the absence of corticosteroid therapy
- •are al-lowed to enrol. Brain metastasis must be stable with verification by
- •imaging (e.g. brain MRI or CT completed at screening demonstrating no current
- •evidence of pro-gressive brain metastases). Patients are not permitted to
- •receive enzyme inducing anti-epileptic drugs or corticosteroids;
- •5. History of cardiac disease, including myocardial infarction within 6 months
- •before first dose of study medication, unstable angina pectoris, New York Heart
- •Associa-tion Class III/IV congestive heart failure, or uncontrolled
- •hypertension, major cardiac abnormalities, a predisposition for developing
- •aneurysms including family history of aneurysms, Marfan syndrome, bicuspid
- •aortic valve, or evidence of damage to the large vessels of the heart;
- •6. Treatment with CYP3A4 inducers or inhibitors and/or concomitant treatment
- •with CYP2C9 substrates with narrow therapeutic window, including but not
- •limited to vit-amin K antagonizing anticoagulants (e.g. acenocoumarol,
- •phenprocoumon and war-farin) and phenytoin is not allowed;
- •7. Impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the absorption of oral galunisertib (e.g., ulcerative
- •diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome,
- •major small bowel surgery);
- •8. Woman who are pregnant or breast feeding;
- •9. Patients who have undergone any major surgery within the last 2 weeks prior
- •to starting study drug or who would not have fully recovered from previous
- •10. Active infection requiring systemic antibiotics or uncontrolled infectious
- •11. Patients with a known history of hepatitis B or C or known Human
- •Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- •12. Other severe, acute, or chronic medical or psychiatric condition or
- •laboratory abnor-mality that may increase the risk associated with study
- •participation or study drug administration or that may interfere with the
- •interpretation of study results and, in the judgment of the investigator, would
- •make the patient inappropriate for the study;
- •13. Known hypersensitivity to one of the study drugs or excipients.
- •14. For women of childbearing potential: agreement to remain abstinent (refrain
- •from heterosexual intercourse) or use contraceptive methods with a failure rate
- •of <1% per year (when used consistently and correctly) during the treatment
- •period and for at least 90 days after the last dose of galunisertib and/or
- •capecitabine.
- •15. For men: agreement to remain abstinent (refrain from heterosexual
- •intercourse) or use contraceptive measures, and agreement to refrain from
- •donating sperm.
研究者
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