NL-OMON54108撤回2 期
A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination with Gemcitabine in Adult and Pediatric Subjects with Relapsed or Refractory Osteosarcoma. - ZN-c3 with Gemcitabine in Subjects with Relapsed or Refractory Osteosarcoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 4
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
- 12 至 99（—）
入选标准
- •An individual must meet all the following criteria to participate in this
- •1. Provision of written informed consent by subjects and/or their
- •parents or legally authorized
- •representatives; assent, when appropriate, will be obtained according to
- •institutional
- •guidelines.
- •2. Age >=12 years old at the time of informed consent.
- •3. Body weight >=40 kg.
- •4. Histologically documented relapsed or metastatic osteosarcoma, as
- •confirmed at the local study site.
- •a) The disease must have failed standard therapy and there is no known curative
- •therapy available, or any available standard of care therapy was not tolerated.
- •b) The Investigator must confirm that gemcitabine is an appropriate
- •treatment approach.
- •c) Subjects may have had any number of prior therapies and prior
- •treatment with gemcitabine is allowed.
- •5. Must have measurable disease according to RECIST v1.1 criteria.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2 for
- •>=16 years of age or Lansky PS >=50 for subjects <16 years of age.
- •7. Adequate hematologic and organ function.
- •8. Ability and willingness to take oral medication.
- •9. Willingness to release archival tissue (less than 2 years old and of
- •adequate tumor cellularity
- •as described in Laboratory Manual; other cases may be considered after
- •discussion with the Sponsor) for research purposes and/or to undergo a tumor
- •tissue biopsy prior to dosing on Cycle 1 Day 1 if >=18 years old.
- •Biopsy samples of tumor tissue should be obtained if, in the judgment of the
- •Investigator, the procedure is considered to be free of unacceptable risk. If
- •in the opinion of the investigator a tumor tissue biopsy is not freeof
- •unacceptable risk and archival tissue is not available, eligible patients may
- •be allowed onto the trial on a case-by-case basis after consultation with the
- •10. Female subjects of childbearing potential must have a negative
- •serum beta human chorionic
- •gonadotropin (β-hCG) test.
- •11. Female subjects of childbearing potential and male subjects must
- •agree to use a highly effective method of contraception from the start of
- •Screening period and for 6 months after the last dose of ZN-c3 and/or
- •gemcitabine.
- •12. Willingness and ability to comply with scheduled visits, treatment plan,
- •laboratory tests, and other study procedures.
排除标准
- •Individuals meeting any of the following criteria will be excluded from this
- •1. Any of the following treatment interventions within the specified timeframe
- •prior to Cycle 1 Day 1:
- •a. Major surgery <28 days (the surgical incision should be fully healed prior
- •to study drug administration).
- •b. Any chemotherapy <21 days or 5 half-lives (whichever is shorter).
- •c. Prior radiotherapy <14 days.
- •d. Any investigational drug therapy <28 days or 5 half-lives (whichever is
- •e. Inability to discontinue treatment with prescription or non-
- •prescription drugs, or to discontinue consumption of food and herbal
- •supplements, that are strong and moderate CYP3A inhibitors and
- •inducers, or P-gp inhibitors at least 14 days prior to Cycle 1 Day1.
- •2. Unresolved toxicity of Grade >1 attributed to any prior therapies
- •(excluding Grade neuropathy, alopecia, or skin pigmentation).
- •3. Prior therapy with a WEE1 inhibitor.
- •4. Known hypersensitivity to gemcitabine or its excipients.
- •5. Known hypersensitivity to any drugs similar to ZN-c3 in class.
- •6. A serious illness or medical condition(s) including, but not limited to,
- •the following:
- •a. Brain metastases that require immediate treatment or are clinically
- •orradiologically unstable (i.e., have been stable for <1 month). If
- •receivingsteroids, subjects must be receiving a stable dose or a decreasing
- •corticosteroid dose during at least 1 week before enrollment.
- •b. Leptomeningeal disease that requires or is anticipated to require
- •immediate treatment.
- •c. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart
- •disease, significant valvular dysfunction, hypertensive heart
- •disease, and congestive heart failure) resulting in heart failure by New York
- •Heart Association Criteria (Class III or IV).
- •d. Other severe acute or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase the risk associated with study
- •participation or study drug administration, or may interfere with the
- •interpretation of study results, and in the judgment of the Investigator would
- •make the subject inappropriate for entry into this study.
- •e. Significant gastrointestinal abnormalities, requirement for IV
- •alimentation, active peptic ulcer, chronic diarrhea, or vomiting
- •considered to be clinically significant in the judgment of the
- •Investigator, or prior surgical procedures affecting absorption.
- •f. Active or uncontrolled infection. Subjects with an infection receiving
- •treatment (antibiotic, antifungal, or antiviral treatment) must have
- •completed such treatment and the infection must be considered
- •controlled/resolved by the investigator before enrollment.
- •7. Pregnant or lactating females or females of childbearing potential
- •who have a positive serum pregnancy test within 14 days prior to Cycle 1Day 1.
- •8. Subjects with active (uncontrolled, metastatic) second malignancies or
- •requiring therapy.
- •9. Individuals who are judged by the Investigator to be unsuitable as
- •study subjects.
- •10. 12-lead ECG demonstrating a corrected QT interval using Fridericia s
- •formula (QTcF) of
- 另有 4 项未显示
研究者
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