NL-OMON47513已完成不适用
A Phase I, Open-Label Study to Determine the Effect of Repeat Dosing of Trametinib on the Pharmacokinetics of a Combined Oral Contraceptive (Norethindrone plus Ethinyl Estradiol) in Female Patients with Solid Tumors - Novartis CTMT212X2102
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 2
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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:;1. Is a female patient * 18 years but < 59 years of age at the time of signing the informed consent.;2. Has a histologically or cytologically confirmed diagnosis of a solid tumor malignancy (except for any excluded malignancies listed in Section 5.3 Exclusion Criteria) that is not responsive to standard therapy(ies) or for which there is no approved therapy.;3. Has a body mass index (BMI) within the range of 19 to 40 kg/m2 (inclusive).;4. Is a non-smoker or is willing to abstain from use of tobacco and/or nicotine-containing products from time of Screening until the EoT visit.;5. Meets one of the following criteria:
- •- Is currently on a stable regimen of an oral contraceptive containing 1mg NE and 0.035mg EE, or
- •- Is willing to switch to a regimen of an oral contraceptive containing 1mg NE and 0.035mg EE from a stable regimen of an alternate OC, or
- •- Is willing to start a regimen of an oral contraceptive containing 1mg NE and 0.035mg EE.;6. Meets one of the following criteria:
- •- Is post-menopausal. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment (based on local practice) is she considered not of child bearing potential.;- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during dosing and for four months after stopping medication. Highly effective contraception methods include
- •- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.;- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment (based on local practice).;- Male partner sterilization (at least 6 months prior to screening). The vasectomized male partner must be the sole partner for that patient. ;- Non-drug eluting intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year. Note: use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception (for example hormone vaginal ring or transdermal hormone contraception) are not permitted.;Note: Females who no longer have regular periods or are menopausal as a result of prior anti-cancer treatment may participate providing they agree to use a highly effective method of contraception as outlined above for at least 14 days prior to the first dose of study treatment until four months after the last dose of study treatment.;7. Has no prior treatment-related toxicities > Grade 1 (except alopecia) at the time of enrolment.;8. Is able to
排除标准
- •Patients eligible for this study must not meet any of the following criteria:;1. Had prior exposure to a MEK inhibitor.;2. Has one of the following excluded tumor types as trametinib therapy has been shown to have minimal benefit in these populations:
- •- BRAF V600E mutant melanoma and failed prior BRAF inhibitor therapy.
- •- Metastatic pancreatic cancer.;3. History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
- •- Recent myocardial infarction (within last 6 months).
- •- Uncontrolled congestive heart failure.
- •- Unstable angina (within last 6 months).
- •- Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker). Note: Patients with controlled atrial fibrillation for >30 days prior to enrolment are eligible.;- History of coronary angioplasty, or stenting within last 6 months.;- History or evidence of current * Class II congestive heart failure as defined by New York Heart Association (NYHA).;- Has an intra-cardiac defibrillator.;- Has a Fridericia-corrected QT (QTcF) interval *460 msec at Screening.;- Has a LVEF, as measured by ECHO (preferred) or MUGA scan, below the institutional LLN, or if a LLN does not exist at an institution, <50%.;4. Has had any major surgery, extensive radiotherapy, or anti-cancer therapy (e.g., chemotherapy with delayed toxicity, biologic therapy, or immunotherapy) within 21 days prior to enrolment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrolment. Prolonged immobilization must have resolved prior to enrolment.;5. Has a known or suspected carcinoma listed below that is excluded (as administration of a combination OC would be contraindicated):;- Carcinoma of the breast.;- Carcinoma of the endometrium.;- BRCA+ ovarian cancer.;- Other known or suspected estrogen-dependent neoplasia.;- Hepatocellular carcinoma.;6. Has a history of another malignancy.;Exception: A patient who has at least one of the following conditions:;- Been disease-free for 3 years.;- History of completely resected non-melanoma skin cancer.;- Indolent second malignancy, other than any of the excluded malignancies listed in;Exclusion Criteria 3.;7. Has a life expectancy of < 3 months.;8. Has a history of interstitial lung disease or pneumonitis.;Further exclusion criteria and details are described in the protocol
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