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Study Title Principal Investigator
0C-12-1-A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients [A8081012]
This is a research study for advanced cancer with varying degree of liver function (normal, mild impairment, moderate impairment or severe impairment). The main purposes of this research study are to see whether a newly approved drug, crizotinib (Xalkori), can be used in patients with liver function that is not normal and to see whether crizotinib can prevent or slow down your cancer from growing, and to assess any side effects that you may have. Some other purposes of this study are to measure how much crizotinib is in your blood, and to provide dosing recommendations for patients with impaired liver function. Crizotinib is approved in the United States (US) and is available by prescription for non-small cell lung cancer (NSCLC) patients with Anaplastic Lymphoma Kinase (ALK) mutation. However, the use of crizotinib in this study is experimental. Crizotinib is not currently approved to treat other advanced cancer patients with unclear ALK status and/or with liver function that is not normal. . The participants of this study will be in this study until their disease progresses (gets worse), they experience unacceptable side effects or they withdraw consent. There will be about 50 advanced cancer patients enrolled in this study. The study is being done at about 3-5 different research sites in US. About 45 participants will take part at USC. This is a multicenter, open-label, non-randomized, phase 1 study. The endpoints are how the drug behaves in the body when taken (pK), effectiveness and safety of the study drug. There will be 5 groups (Groups A1, A2, B, C and D) involved in this study. Groups A1 and A2 have normal liver functions. Group A1 will match Group B(mild) and Group A2 will match Group C(moderate).The study drug is given by mouth and should be taken at approximately the same time each day on a continuous daily dosing.One-way analysis of variance (ANOVA) will be used for statistical analysis. Individual concentration of the study drug in the blood will be listed and summarized. The safety analysis population will include all enrolled patients who receive at least one does of crizotinib. The safety analysis population will be the primary population for evaluating patient characteristics, treatment administration and safety. Safety data will be reviewed on an ongoing basis during the study.
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
Anthony El-Khoueiry
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A Phase 1, Open-Label Study Assessing the Impact of Hepatic Impairment on the Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
Masaya Tachibana
0C-14-2: An Open-Label, Phase 2 Study of Neratinib in Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (Egfr, Her2, Her3) Mutations or EGFR Gene Amplification
This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene amplified solid tumors. Neratinib (PB-272) is a small molecule that inhibits EGFR, HER2, and HER4. Aberrant expression of EGFR, HER2, and HER3 are linked to development of many epithelial cancers including colorectal, gastric, breast and head and neck cancers. Preclinical data suggest that neratinib will have antitumor activity in EGFR- and/or HER2-expressing carcinoma cell lines. The study will include the following cohorts of patients with tumors harboring somatic ERBB (EGFR, ERBB2, ERBB3) mutations or EGFR gene amplification. 1. Bladder/Urinary Tract ERBB2 Mutant - Neratinib 240mg daily + Paclitaxel 80mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle 2. Biliary Tract ERBB2 mutant HR Negative- Neratinib 240mg daily 3.Breast a. ERBB2 mutant HR Negative - Neratinib 240mg daily b. ERBB2 mutant HR Positive - Neratinib 240mg daily + Fulvestrant 500mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle 4. Endometrial ERBB2 mutant - Neratinib 240mg daily 5. Gastroesophageal ERBB2 mutant - Neratinib 240mg daily 6. Ovarian ERBB2 mutant - Neratinib 240mg daily 7. Solid tumors (NOS) ERBB2 Mutant - Neratinib 240 mg daily *Cohorts given combination therapy are "Combination Therapy" and all cohorts given Neratinib alone are labeled "Monotherapy." The following cohorts have closed to accrual: 1. EGFR mutation and/or EGFR amplification Primary brain tumors Cohort: Primary brain tumors (glioblastoma multiforme [GBM] Grade III, glioma, gliosarcoma) Closed to Accrual The trial will consist of a screening period, a treatment period, safety follow-up and end of treatment (EOT) assessments, follow-up for disease progression every 8 weeks, and a survival follow-up period. Treatment will consist of neratinib by mouth with food once daily in the morning administered on a continuous basis or combination therapy as listed above. The primary endpoint of this study for all cohorts is to determine the objective response rate at 8 weeks (ORR8) following treatment with neratinib. The secondary objectives of this study are: To determine the confirmed objective response rate (ORR) according to RECIST v1.1 or other defined response criteria with neratinib monotherapy and combination therapy. To determine the clinical benefit rate (CBR) of neratinib monotherapy and combination therapy. To determine PFS. To determine change in tumor growth rate for patients with primary brain tumors. To determine the duration of response (DOR) of neratinib monotherapy and combination therapy, defined as the time from which measurement criteria are met for overall response of CR and PR until the first date of documented disease progression. To determine overall survival (OS). To determine the role of dual modality PET/CT scans in measuring metabolic response to neratinib monotherapy and combination therapy. To assess the safety profile and tolerability of neratinib monotherapy and combination therapy. To assess Patient Reported Outcomes using the EuroQol EQ-5D-5L instrument. A Simon 2-stage optimal design will be used to determine whether neratinib has sufficient activity to warrant further development in the following cohorts: colorectal, endometrial, gastroesophageal, ovarian, and listed breast cancers. At the end of the trial, a 2-sided 80% confidence interval for Objective Response Rate will be determined for each cohort separately using the method of Koyama and Chen (2008). Patient-related outcomes (EQ-5D-5L instrument) will be summarized and plotted over time. Changes from baseline will be provided with both point estimates and confidence intervals. All analyses are descriptive and no formal testing is planned.
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
David Quinn
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