Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three [ Read More ]
Clinical Trials Under Way for Patients with Renal-Cell Carcinoma
Clinical Trials Under Way for Patients with Renal-Cell Carcinoma
The following clinical trials are currently recruiting patients with renal-cell carcinoma for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.
Dalantercept with or without Axitinib
This phase 2, randomized, double-blind, 2-part study aims to evaluate the safety, tolerability, and recommended dose level of dalantercept in combination with axitinib in part 1, and compare progression-free survival (PFS) between the above combination therapy versus axitinib alone in part 2. Patients with clear-cell renal-cell carcinoma who are aged ≥18 years may enroll if they have experienced disease progression after ≤3 lines of therapy, and if other criteria are met. Patients will receive axitinib orally twice a day with an injection of dalantercept or placebo once every 3 weeks.
The primary outcome of part 1 in the study is the number of patients with adverse events, and of part 2 is PFS. Part 2 has secondary outcome measures of overall survival (OS), time to tumor progression, objective response rate, duration of response, and disease control rate. Pharmacodynamic biomarker activities are also assessed. This study is expected to enroll 174 patients in many sites across the United States. For more information, contact the clinical trials manager at clinical email@example.com. The NLM Identifier is NCT01727336.
Entinostat with Aldesleukin
The objective of this phase 1/2 study is to determine the side effects and best dose of entinostat when given with aldesleukin to patients with metastatic or surgically unresectable renal-cell carcinoma. Patients aged ≥18 years may enroll if they have received ≤2 therapies, have an Eastern Cooperative Oncology Group (ECOG) performance score of 0, and if other criteria are met. Patients will receive oral entinostat once every 2 weeks starting 2 weeks before and throughout combination treatment with aldesleukin. High-dose intravenous aldesleukin is given every 8 hours on days 1 to 5 and 15 to 19. Courses repeat every 84 days in the absence of disease progression or unacceptable toxicity.
Primary outcome measures include the recommended dose of entinostat when given in combination therapy and the overall response rate. Secondary outcomes include the incidence of toxicities in phases 1 and 2, and PFS and time to tumor progression in phase 2. Changes in level of specific T lymphocytes and tumor metabolisms are also assessed. This study is expected to enroll 54 patients in California, Maryland, New York, and Ohio. For more information, contact Roberto Pili, MD, at 716-845-3117 or firstname.lastname@example.org. The NLM Identifier is NCT01038778.
AZD6094 (HMPL-504) for Papillary Renal-Cell Carcinoma
This phase 2, open-label trial examines the efficacy of AZD6094 (HMPL-504) in treatment-naïve or previously treated patients with papillary renal-cell carcinoma. Patients aged ≥18 years may enroll if they have an ECOG performance score of 0 or 1, adequate hematologic and liver functions, a glomerular filtration rate of ≥40 mL/min, and if other criteria are met. All patients will receive oral AZD6094 600 mg daily.
The primary outcome measure is the antitumor activity of AZD6094 as defined by the percentage of patients with an incidence of complete or partial response that is confirmed ≥4 weeks later. The secondary measures include the PFS, safety and tolerability, and pharmacokinetics of the experimental drug. Changes in target lesion tumor size from baseline, duration of response, and OS are also assessed. All outcomes are assessed for ≤7 months. This trial is expected to enroll 75 patients in many locations throughout the United States. To locate a site, contact the Cancer Study Locator at 877-400-4655 or email@example.com. For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479 or firstname.lastname@example.org. The NLM Identifier is NCT02127710.
Adjuvant Axitinib Therapy in High-Risk Patients
The purpose of this phase 3 trial is to determine whether adjuvant therapy with axitinib will prevent or delay the recurrence of renal-cell carcinoma in patients with high risk for the disease after surgery. Patients aged ≥18 years who have been treated with nephrectomy and have no evidence of macroscopic residual disease or metastatic disease may enroll if other criteria are met. Patients are randomized in a 1:1 ratio to receive a placebo or 5 mg of axitinib twice a day.
The primary outcome is disease-free survival. Secondary outcomes include OS and the safety profile of both treatment arms. All outcomes are assessed for 5 years. This study is expected to enroll 592 patients in multiple locations throughout the United States. For more information, contact Rolf Linke, MD, at 650-954-0106 or email@example.com, or Clinton White, PhD, at 925-963-8696 or firstname.lastname@example.org. The NLM Identifier is NCT01599754.
Pazopanib for Metastatic Non–Clear-Cell Renal-Cell Carcinoma
The objective of this phase 2, open-label, single-arm trial is to study how well pazopanib hydrochloride works in treating patients with metastatic non–clear-cell renal-cell carcinoma. Patients aged ≥18 years with an ECOG performance score of 0, 1, or 2 who have received ≤1 treatment other than pazopanib may enroll if other criteria are met. All patients will receive oral pazopanib hydrochloride daily for 28 days. The course will repeat every 28 days in the absence of disease progression or unacceptable toxicity.
The primary objective is OS, defined as the percentage of patients who survive 12 months of treatment. Secondary outcome measures include tumor response rate, PFS, and adverse event rate, which are all assessed ≤2 years after treatment completion. This trial is expected to enroll 39 patients in Scottsdale, AZ, and Rochester, MN. For more information, contact the Clinical Trials Referral Office at 855-776-0015. The NLM Identifier is NCT01767636.
Autologous Dendritic-Cell Immunotherapy (AGS-003) plus Standard Treatment
This phase 3, open-label, randomized trial compares the OS benefit between patients who receive standard treatment plus AGS-003 and those who receive standard treatment alone; tumor collection will take place as part of this study. Patients aged ≥18 years with advanced renal-cell carcinoma may qualify for tumor collection if they are scheduled for cytoreductive or partial nephrectomy. Patients may receive treatment if they have been diagnosed within a year, have a Karnofsky performance status of ≥70, and a life expectancy of ≥6 months. All patients will receive standard treatment with sunitinib, and the experimental group will also receive AGS-003, an intradermal injection of an autologous dendritic-cell product.
Primary outcome measures include OS, PFS, and tumor response. The number of emergent adverse events that require treatment is also assessed. This trial is expected to enroll 450 patients throughout many locations in the United States. For more information, contact the Adapt Study Team at 877-573-9235 or email@example.com. The NLM Identifier is NCT01582672.
Everolimus Efficacy Postsurgery
This phase 3, randomized, double-blind, parallel-group trial assesses the efficacy of everolimus in treating patients with renal-cell carcinoma who have received a partial or radical nephrectomy. Patients aged ≥18 years who had their first surgical resection within 84 days of study registration may enroll if other criteria are met. Patients are randomized to receive oral everolimus or placebo daily for 42 days, with the cycle repeating every 6 weeks. The treatment is given for up to 54 weeks in the absence of disease progression.
The primary outcome measure is to compare recurrence-free survival between the 2 groups, and the secondary outcomes are to compare OS and toxicity between the 2 groups. This study is expected to enroll 1218 patients at sites throughout the United States. For more information, contact Gilbert Carrizales at 210-614-8808 or firstname.lastname@example.org, or Dana Sparks, MAT, at 210-614-8808 (extension 1004) or email@example.com. The NLM Identifier is NCT01120249.
Sunitinib versus Placebo
The objective of this phase 3, randomized, double-blind, parallel-group study is to compare the disease-free survival rate and safety of sunitinib versus placebo in patients who receive adjuvant treatment and who are at high risk for recurrent renal-cell carcinoma after surgery. Patients aged ≥18 years with high-risk renal-cell carcinoma, an ECOG performance score of 0 to 2, and who are treatment-naïve may enroll if other criteria are met. Patients are randomized to sunitinib malate 50 mg orally or placebo in a 4-weeks-on, 2-weeks-off regimen for a year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
The primary outcome measure is the disease-free survival comparison between the 2 groups, assessed for a time frame of 36 months. Secondary outcome measures include OS, safety, tolerability, and patient-reported outcomes. This study is expected to enroll 720 patients at sites throughout the United States. For more information, contact the Pfizer CT.gov Call Center at 800-718-1021. The NLM Identifier is NCT00375674.
Lexicon Pharmaceuticals Reports Positive Top-Line Results for Pivotal Phase 3 Telotristat Epitrate Study in Cancer Patients with Carcinoid Syndrome
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