NL-OMON38109已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients with Metastatic or Locally Advanced (Unresectable) Chondrosarcoma - Study of IPI-926 in patients with chondrosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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 are eligible for inclusion in the study if they meet the following criteria:
- •1. At least 18 years of age at the time of signing informed consent.
- •2. Pathologically diagnosed conventional chondrosarcoma. (Note: Patients must have tumor sample(s) available or provide tumor samples from a new biopsy for central confirmation of diagnosis. Central pathology review will be completed after randomization. The most recent tumor tissue sample will be used for diagnosis.)
- •Note: Please carefully ensure that the pathology indicates conventional chondrosarcoma. Less common subtypes such as dedifferentiated, mesenchymal, and clear cell chondrosarcomas
- •are NOT conventional chondrosarcoma. Please be aware that *extraskeletal myxoid chondrosarcoma* is not truly a chondrosarcoma (despite the retention of this historical term by pathologists and oncologists) and patients with this pathology are NOT eligible for the study.
- •3. Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon.
- •4. At least 1 radiologically measurable target lesion per RECIST 1.1. If the lesion has received prior radiotherapy, then progression of the lesion (defined as radiographic growth of the lesion by at least 20%) must have occurred since the completion of radiation.
- •5. Patients must have documented radiographic progression of disease within the 6-month period prior to screening. Note: RECIST-defined radiographic progression of disease will be
- •based on at least two sets of scans (either MRI or CT) taken during the period of time from 6 months prior to the date of signing study consent through the start of study drug dosing. The second of these two scans may be the baseline scan. Central review of eligibility
- •scans will be performed.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
- •7. Life expectancy of at least 3 months.
- •8. Recovery to <= Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia.
- •9. All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug. Women of child-bearing potential (defined as
- •a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months for women <=55 years, for women >55 years 12 consecutive months) must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
- •10. Ability to adhere to the study visit schedule and all protocol requirements.
- •11. Voluntarily signed an informed consent form.
排除标准
- •Patients are to be excluded from the study if they meet any of the following criteria:
- •1. Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
- •2. Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
- •3. Prior treatment with a Hedgehog pathway inhibitor.
- •4. Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1.
- •5. Inadequate hematologic function defined by:
- •Hemoglobin <8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
- •6. Inadequate hepatic function defined by:
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN).
- •Total bilirubin >1.5 x ULN (with the exception of patients with Gilbert*s disease).
- •Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
- •7. Inadequate renal function defined by serum creatinine >1.5 x ULN.
- •8. Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- •9. Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
- •10. Significant co-morbid condition or disease, which in the judgment of the Investigator, would place the patient at undue risk or interfere with the study. Examples include, but are not limited to sepsis and recent significant traumatic injury.
- •11. Known human immunodeficiency virus (HIV) positivity.
- •12. Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo capsules.
- •13. Pregnant or lactating women.
- •14. Current administration of the medications or foods which are known to be moderate or strong inhibitors of CYP3A4 activity (see Appendix 1).
研究者
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