Solid Tumor/Phase I Clinical Trials

Showing 31-42 of 42 items
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  • A Study of the Safety, Tolerability, and Efficacy of SCH 900353 in Participants With Advanced Solid Tumors (P06203 AM2)
  • This study of the safety, tolerability, and efficacy of SCH 900353 given as single agent oral therapy for participants with advanced solid tumors will be done into two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2 dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to see if SCH 900353 is effective as single agent therapy.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers
  • Primary Objective: - To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Secondary Objectives: - To characterize the global safety profile of SAR245408 in combination with SAR256212 - To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination - To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only) - To determine the immunogenicity of SAR256212 as administered with SAR245408
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer
  • Primary Objective: Part A - Monotherapy: - To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and either on a once or twice daily schedule, to patients with advanced solid tumors or lymphomas. Part B - Combination: - To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with the recommended standard dosage of Vemurafenib to patients with unresectable / metastatic v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma. Secondary Objectives: - To characterize the overall safety and tolerability profile of SAR260301 administered as monotherapy (Part A) and in combination with Vemurafenib (Part B). - To characterize the pharmacokinetic (PK) profile of SAR260301 administered as monotherapy (Part A) and in combination with Vemurafenib (Part B) as well as Vemurafenib PK in combination with SAR260301 (Part B) - To evaluate food effect on SAR260301 PK (Part A) - To assess preliminary antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). - To assess preliminary antitumor activity using volumetric computed tomography (CT) or magnetic resonance imaging(MRI) - To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor. - To evaluate PK/PD relationships. - To identify the recommended phase 2 dose of SAR260301 in combination with Vemurafenib (RP2D) (Part B only) - To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A (CYP3A) (Part A)
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Safety, PK of AKT and MEK Combination
  • This study is a Phase 1 dose-escalation open-label study to determine the recommended Phase II dose and regimen for the combination of the orally administered MEK inhibitor GSK1120212 and the orally administered AKT kinase inhibitor GSK2141795. The recommended dose and regimen of the combination in Part 2 will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of subjects with solid tumors in Part 1. The study consists of two parts. Part 1 will identify the maximum tolerated dose using a Zone-Based, modified 3+3 dose escalation procedure. Dose escalation will continue based on predefined parameters until a maximum tolerated dose is established. The initial regimen will be continuous oral daily dosing. This regimen may be adjusted based on emerging data. Part 2 will explore further the safety, tolerability, and clinical activity of the combination of GSK1120212 and GSK2141795 at the recommended dose(s) identified in Part 1 in up to 40 subjects with pancreatic cancer, endometrial cancer or colorectal cancer.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
Showing 31-42 of 42 items
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