EUCTR2011-002803-13-GB进行中（未招募）1 期
A Randomised, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian Cancer - MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
入选标准
- •(1) Patient must have a histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, or primary peritoneal cancer that has progressed after paclitaxel / platinum based therapy.
- •(2) Patients must have platinum sensitive disease. Progression must have occurred 6 months or more after the completion of the most recent platinum based treatment.
- •(3) Patient is able to provide a baseline tumour sample. The submitted tumour sample must have tested positive for a loss-of-function p53 mutation as defined in the assay charter (copy enclosed) and the result must be documented by the core lab for the study.
- •(4) Part 1 - Patient may not have received more than two platinum containing treatment regimens for their cancer. Part 2 - Patient may not have received more than three separate regimens of platinum containing treatment for their cancer. (The UK will only participate in part 2 of the study)
- •(5) Any biologic therapy or radiation must have been completed four weeks prior to receiving study therapy. With the exception of alopecia, the patient must have recovered to = Grade 1 from adverse events due to previous agents administered. Biologic maintenance therapy (i.e. bevacizumab) is allowable within this six month period. Any biologic maintenance therapy must have been discontinued 28 days prior to the patient starting study therapy.
- •(6) Patient has measurable disease based on RECIST 1.1 criteria
- •(7) Patient is =18 years of age on day of signing informed consent.
- •(8) Patient has a performance status of =1 on the ECOG Performance Scale.
- •(9) Patient must have adequate organ function
- •(10) Female patient of childbearing potential has a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
- •(11) Patient has voluntarily agreed to participate by giving written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 119
排除标准
- •(1) Patient is currently participating or has participated in a study with an investigational compound or device within 28 days of receiving first dose of study medication.
- •(2) Patients with active CNS (central nervous system) metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids for at least 2 weeks.
- •(3) Patient with a primary central nervous system tumour.
- •(4) Patient has known hypersensitivity or contraindications to the components of potential study therapy (paclitaxel, carboplatin, MK-1775) or its analogs (i.e. cremophor, mannitol, etc). The MK-1775 Investigator Brochure can be referenced for information regarding study therapy.
- •(5) Patient has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to potent inhibitors / inducers of CYP3A4 or inhibitors of CYP2C8, which cannot be discontinued two weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication.
- •(6) Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate. Patients with carcinoma in situ of the cervix or basal cell carcinoma of the skin will be permitted enrollment.
- •(7) Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •(8) Patient is, at the time of signing informed consent, a known regular user(including recreational use of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
- •(9). Patients expecting to reproduce within the projected duration of the study, and
- •women who are pregnant or breastfeeding.
- •(10). Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
- •(11). Patient has known active Hepatitis B or C.
- •(12). Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible for the study however.
- •(13). Patient has a clinical history suggestive of Li Fraumeni Syndrome
研究者
相似试验
进行中（未招募）
1 期
MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin AloneEUCTR2011-002803-13-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.119
进行中（未招募）
1 期
MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin AloneEUCTR2011-002803-13-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.119
进行中（未招募）
1 期
MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin AloneMedDRA version: 18.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864Ovarian cancerEUCTR2011-002803-13-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.119
进行中（未招募）
1 期
A Two Part, Phase I-IIa Study Evaluating MK-1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical CancerPatients with advanced, metastatic, and recurrent carcinoma of the uterine cervixMedDRA version: 12.1Level: LLTClassification code 10008229Term: Cervical cancerEUCTR2009-017054-12-FRMerck & Co., Inc.132
进行中（未招募）
1 期
Clinical Trial of MK-7684A with chemotherapy for extensive stage small cell lung cancer (ES-SCLC)Extensive-stage small-cell lung cancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-005034-42-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.450