Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer
PRIMARY OBJECTIVES:
I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC)
treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA)
decline of >= 50% from baseline.
SECONDARY OBJECTIVES:
I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine
in prostate cancer patients.
II. To assess time to radiographic disease progression for patients with recurrent prostate
cancer treated with phenelzine.
III. To collect blood and other samples to study the relationship between MAO activity and
prostate cancer.
OUTLINE:
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of
15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been
treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade <
or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating
investigator. Treatment may continue in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 3
years.
3C-14-1: A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer
This is a Phase 2 open-label, multi-center, 2-stage Simon design stage trial of nivolumab (BMS-936558) monotherapy (mStage) or in combination with ipilimumab (cStage) to estimate the response rate in Metastatic Microsatellite MSI-High colon cancer. Ipilimumab is a fully humanized IgG1 monoclonal antibody binding to the anti-cytotoxic T-cell lymphoma-4 antigen (CTLA-4). Ipilimumab is an approved therapy for metastatic melanoma.Nivolumab (BMS-936558; anti-PD-1 mAb) is a fully human monoclonal immunoglobulin (Ig) G4 antibody that binds to the programmed death-1 (PD-1), a negative regulatory molecule expressed by immune cells.Primary Objective of the study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with metastatic MSI-H colon cancer.The study will also contain a safety cohort of subjects with non-MSI-H colon cancer to assess the safety and tolerability of nivolumab in combination with ipilimumab in subjects with non-MSI-H colon cancerBoth Arms N and N+I will follow a two-stage design to test whether nivolumab monotherapy or nivolumab combined with ipilimumab yields an objective response rate (ORR) that is of clinical interest in MSI-H metastatic colorectal cancer mCRC. On treatment stages that meet an ORR threshold will proceed from Stage 1 to Stage 2 (same for both m and cStage). The primary endpoint of this study ORR which is based on tumor assessments at baseline and then at 6 weeks from first dose and continue every 6 weeks for the first 24 weeks and every 12 weeks thereafter until disease progressionThe study will enroll 96 patients out of which 15 will be enrolled at USC
Not recruiting | Colon / Rectal Cancer | Multisite
A PHASE IIIb, MULTICENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF DYSPORT USING 2 mL DILUTION IN ADULTS WITH CERVICAL DYSTONIA A-TL-52120-169
A multicentre, randomised, double blind, placebo controlled study where at study entry, subjects will be randomised in a ratio of 2:1 to receive either Dysport or placebo. The primary objective of the study is to evaluate the efficacy and safety of Dysport 500 units (U)/vial using 2 mL dilution compared with placebo for the treatment of cervical dystonia (CD). All subjects are planned to have a single treatment in this study. Following study treatment, follow up visits will be performed at Week 2, Week 4 and Week 12 (+28 days/4 weeks) or early withdrawal due to any reason. All subjects who complete the Week 12 visit will be considered to have completed the study and will be offered entry into an open label extension (OLE) study, which consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Between Weeks 4 and 8, subjects may be deemed eligible for early entry into the OLE study, i.e. before they reach the planned Week 12 study visit if rescue treatment is needed. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from baseline in TWSTRS total score at Week 4. Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. Therefore, in this clinical study the majority of enrolled subjects will be previously treated with Botox to reflect the real world clinical scenario in the USA.Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS. Exploratory analysis will be performed for each of the tertiary secondary efficacy endpoints using appropriate methods.
A Phase 3b, Prospective, Multicenter, Open-Label Extension Study to Assess Long Term Safety and Efficacy of DYSPORT Using 2mL Dilution in Adults with Cervical Dystonia
A phase 3b, prospective, multicenter, open-label extension study to assess the long term safety and effectiveness of Dysport using 2 mL dilution in adults with cervical dystonia. This study is open to subjects who have completed the Dysport double-blind study protocol A-TL-52120-169 or are eligible for early entry, from enrollment into the 169 study.Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. The primary objective of the study is to assess long term safety of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). Secondary objective is to assess long term efficacy of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). The study consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from treatment cycle baseline (defined as Day 1 in each cycle) in TWSTRS total score at Week 4 and Week 12 visits, in Treatment Cycles 1, 2, and 3. Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS.
Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases
The Phase I part of the study is designed as a randomized cross-over trial, including two
arms: a Control arm and a multi-cycle special 5-day dietary regimen (Diet, 3 cycles) arm.
After 3 cycles, the Control and Diet groups are crossed over such that the Control group will
under-go dieting and the Diet group will return to normal diet. Participants will be
monitored for body weight and physiological changes, as well as the adherence to the dietary
intervention.
The Phase II part of the study is an expansion of the Phase I to ascertain the impact of the
dietary intervention on risk factors for metabolic syndrome and biomarkers associated with
aging and age-related diseases.
Statistical methods: Paired samples t-test and Mann-Whitney test will be used to compare
between Control and Diet groups as well as pre- and post-diet values.
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