EUCTR2010-024518-74-DE进行中（未招募）不适用
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
Infinity Pharmaceuticals, Inc0 个研究点目标入组 140 人开始时间: 2011年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •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.)
- •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 ß human
- •chorionic gonadotropin (ßhCG) 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.
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Other invasive malignancies diagnose 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:
- •Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L).
- •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.
研究者
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