EUCTR2010-024518-74-IT
Active, not recruiting
Not Applicable
Studio di fase 2 a doppio cieco e controllato con placebo per valutare la sicurezza e l'efficacia di IPI-926 in pazienti con condrosarcoma metastatico o localmente avanzato (non resecabile) - ND
INFINITY PHARMACEUTICAL INC.0 sites108 target enrollmentStarted: September 1, 2011Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- INFINITY PHARMACEUTICAL INC.
- Enrollment
- 108
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. At least 18 years of age at the time of signing informed consent. 2\. Pathologically diagnosed conventional chondrosarcoma. 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\. since the completion of radiation. 5\. Patients must have documented radiographic progression of disease within the 6\-month period prior to screening. 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 being less than 1 year post\-menopausal) must have a negative serum or urine ß human chorionic gonadotropin (ßhCG) pregnancy test. Adequate methods of contraception include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo\-Provera, 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?
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •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. XML File Identifier : N7Io6MWImPt8/UDZj0AkdL2KNKY\= 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 significanttraumatic 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
Investigators
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