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110 active trials for Solid Tumors

A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours

This is a Phase 1A/B study consisting of four parts. Part A (completed) is a non-randomised, open-label, sequential evaluation of the safety, pharmacokinetics (PK), maximum tolerated dose (MTD), and recommended dose (RD) of ETC-1922159 in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. Dose escalation, with the goal of identifying the MTD and RD, is guided by an ordinal continual reassessment method (oCRM) model with a cohort size of one patient. Part A extension (completed) is a non-randomised, non-comparative, open-label evaluation of the safety and tolerability of ETC-1922159 together with the bone protective treatment (denosumab) in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. Part B dose escalation will be a non-randomised, open-label, sequential evaluation of the MTD, RD, safety, PK, and PD (pharmacodynamics) of ETC 1922159 in combination with pembrolizumab in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. Part B dose expansion will be a non-randomised, non-comparative, open-label study evaluation of the safety and tolerability of ETC-1922159 as a single agent until disease progression and then in combination with pembrolizumab at the RD identified in the Part B dose escalation segment, in patients with advanced or metastatic, or unresectable solid malignancies that are refractory, intolerant or not suitable for available treatment according to the treating physician. It is anticipated that the study will take approximately 78 months to complete (36 months for Part A and Part A Extension, approximately 6 months for Part B dose escalation and approximately 36 months for Part B dose expansion).

Start: October 2015
Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

Background: - Researchers want to find better ways to treat cancer. One drug that treats cancer is paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if another drug, nilotinib, helps paclitaxel work better. Objective: - To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can be given safely to people. Eligibility: - Adults at least 18 years old with advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with tests they usually get in their cancer care: medical history, physical exam, blood and urine tests, heart test, and scans. Participants will take the two study drugs in 28-day cycles. They will keep a medicine diary. Nilotinib will be taken by mouth twice every day except day 1 of the first cycle. Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will usually be done at the clinic. Most participants will have a weekly study visit every week for cycle 1, then the first 3 weeks of other cycles. They will have: Physical exam at every visit. Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles. Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or they may be ultrasounds, where a wand is pressed on the skin with gel on it. Around 30 days after stopping the study drugs, participants will be called to discuss any side effects.

Start: April 2015