EUCTR2012-003144-80-HR进行中（未招募）1 期
A PHASE IV, POSTMARKETING, OPEN-LABEL, EXTENSION (ROLLOVER) STUDY OF VEMURAFENIB IN PATIENTS WITH BRAFV600 MUTATION-POSITIVE MALIGNANCIES PREVIOUSLY ENROLLED IN AN ANTECEDENT VEMURAFENIB PROTOCO
F. Hoffman-La Roche Ltd.0 个研究点目标入组 215 人开始时间: 2014年9月2日最近更新:
适应症
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
- 215
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
- •Disease-Specific Inclusion Criteria:
- •- BRAFV600 mutation positive malignancy
- •- Prior eligibility and treatment in an antecedent vemurafenib protocol
- •- Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of study in the antecedent protocol
- •General Inclusion Criteria:
- •- Signed informed consent form(s)
- •- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two adequate methods of contraception including at least one method with a failure rate of < 1% per year during the course of this study and for at least 6 months after completion of study treatment.
- •- Females of childbearing potential are defined as sexually mature women without prior hysterectomy who have had any evidence of menses in the past 12 months. In order to be considered NOT of childbearing potential, amenorrhea for a period of 12 months or longer must have occurred in the absence of chemotherapy, anti estrogen therapy, or ovarian suppression.
- •- Effective forms of contraception include surgical sterilization, a reliable barrier method with spermicide, birth control pills, contraceptive hormone implants, or vasectomized partner.
- •- Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential; women of non-childbearing potential may be included if they are either surgically sterile or have been naturally menopausal for = 1 year. Women of non childbearing potential need not undergo the pregnancy test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 133
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 82
排除标准
- •- Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
- •- Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the patient may roll over into the current protocol without sponsor approval. Under special circumstances, when it is felt that the patient may clinically benefit by continued therapy with vemurafenib, enrollment into this protocol and dosing beyond progression may considered, if it is judged by the investigator, in consultation with the Sponsor, to be in the best interest of the patient. All such cases will require approval of the Sponsor before enrolling the patient into this protocol.
- •- Meeting any of the following exclusion criteria of the antecedent study at the time the patient is considered for the extension (rollover) study:
- •- Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside of this study
- •- Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to participate in the study
- •- History of malabsorption or other clinically significant metabolic dysfunction
- •- History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
研究者
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