Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Disease Progression

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Belinostat

Histone Deacetylase Inhibitors

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

This is a one arm, open label study of the investigational medication Belinostat.

Induction therapy will include 6 cycles of 5-days of medication administration followed by a 16 day rest period. Belinostat will be given once a day for 5 days total. Three dose levels will be evaluated (600mg/kg, 800 mg/kg, and 1000 mg/kg). In addition, participants will receive fixed doses of intravenous carboplatin (AUC 6), Paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) once on day 3 of each cycle. Serial disease status evaluations will be done throughout the study.

In the absence of significant toxicity or disease progression, participants may continue with a maintenance regimen of bevacizumab and Belinostat for an additional 6 cycles. The dose of Belinostat received during maintenance will be that tolerated in the initial 6 cycles.

Belinostat, carboplatin, paclitaxel and bevacizumab

Martin E Guiterrez, MD

The purpose of this study is to establish the safest dose of the investigational medication Belinostat that can be administered with a standard of care chemotherapy regimen of bevacizumab, carboplatin, and paclitaxel. Further study will examine the short and long-term effect (up to 2 years) of this medication on participant's disease status and overall survival.

This is a Phase Ib/II, single center, open label, dose-finding study to evaluate the use of Belinostat when given with standard of care chemotherapy in patients with untreated, non-small cell lung cancer (NSCLC). In the Phase Ib portion, dose limiting toxicity evaluation will be used to determine the maximum tolerated dose (MTD) of Belinostat when given with fixed doses of bevacizumab, carboplatin, and paclitaxel(a BelCap-B regimen). Three dose levels of Belinostat are proposed (600mg/kg, 800mg/kg, 1000mg/kg). Determination of MTD will be the basis for establishing set dosing for the phase II component of the study.

The phase II portion of the study includes further drug safety evaluation and a preliminary assessment of efficacy of Belinostat when used with specified induction and maintenance regimens. Response will be evaluated through the RECIST criteria. Additional analysis will be done to estimate the time to response, progression free survival, median survival, and overall survival (OS) in study participants to 2 years post-initiation of cycle 1.

Based on a standard 3 x 3 statistical design, the phase Ib portion may accrue between 3 to 12 participants. Phase II will have a minimum sample size of 10 and a maximum of 16 patients. Participants who complete the Phase I portion and are able to advance to Phase II, will be evaluable for the Phase II objectives.

Safety and Efficacy of Belinostat When Used With Standard of Care Chemotherapy for Untreated Non-small Cell Lung Cancer

Phase Ib/II Study to Determine the Recommended Dose, Safety, and Preliminary Efficacy of Belinostat When Used in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Patients With Untreated Non-small Cell Lung Cancer.

The aim of the initial phase Ib component is to establish the maximum tolerated dose (MTD) of Belinostat when used with a standard of care carboplatin, paclitaxel and bevacizumab course of therapy ("BelCap-B") regimen. The MTD will be determined through the process of dose-limiting-toxicity evaluation.

The percentage of participants who are alive at 2 years post initiation of investigational treatment.

Long-term (up to 2 years) safety evaluation of the investigational treatment will be evaluated by ongoing evaluation of adverse events/late-effects using the NCI Common Toxicity Criteria.

Response to therapy will be measured by the RECIST criteria. The investigators will assess the percentage of research participants whose disease status indicates a response to investigational treatment according to the RECIST criteria.

The number (%) of participants who do not show evidence of disease progression (according to RECIST criteria)at 2 years post initial administration of the investigational product.

Holy Cross Hospital, Florida

Executive Director of Clinical Research

MDG1011 administration of escalating doses

MDG1011 administration of Phase II recommended dose

PRAME-T-Cell Receptor Gene Modified Autologous T Cells

MDG1011

Any intervention/therapy chosen by the investigator

Investigator Choice therapy

Simone Thomas, PD Dr. med.

This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific human leukocyte antigen (HLA)-A\*02:01-restricted T cell receptor (TCR).

Phase I:

The Phase I dose escalation part will establish the MTD/RP2D in subjects with high risk myeloid and lymphoid neoplasms, a total of 3 disease entities.

Phase I subjects will be enrolled into the following cohorts and treated with a single intravenous (i.v.) infusion of IMP:

* Cohort 1: target dose of 1 x 105 T cells/kg ± 20%
* Cohort 2: target dose of 1 x 106 T cells/kg ± 20%
* Cohort 3: target dose of 5 x 106 T cells/kg ± 20%
* Optional cohort 4: up to 1 x 107 T cells/kg + 20%

Phase II:

The Phase II part consists of two arms, each representing one disease entity. Within each arm, representing a disease entity, subjects will be enrolled in 2 different treatment groups to receive either:

1. IMP in the treatment group (up to 20 subjects who are positive for human leukocyte antigen (HLA)-A\*02:01); Or
2. therapy as per Investigator's discretion in the concurrent control (up to 20 subjects who are negative for HLA-A\*02:01).

TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

A Phase I/II, Open-Label, Non-Randomized, Multicentre, Dose-Escalation Clinical Trial With Control Group to Evaluate the Safety, Feasibility and Preliminary Efficacy of PRAME TCR Modified T Cells, MDG1011, in Subjects With High Risk Myeloid and Lymphoid Neoplasms

Incidence and severity of adverse events according to the NCI CTCAE, v4.03; MTD and/or RP2D of IMP measured by dose-limiting toxicities (DLTs) up to 28 days post infusion

Incidence and severity of adverse events according to NCI CTCAE, v4.03

Medigene AG

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

YM155

D. Buell, MD

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma

Astellas Pharma US, Inc.

Astellas Pharma Inc

Digestive System Diseases

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Capecitabine

Antimetabolites

Capecitabine in HCC

Muhammad K Anis, MD

Zaigham Abbas, MD

Wasim Jafri, MD

In patients with unresectable/advanced Hepatocellular Carcinoma receiving Capecitabin, we anticipate that the proposed chemotherapy will have a delay in progression of the disease . It is also expected that proposed chemotherapy will have acceptable toxicity and Quality of life.

II. OBJECTIVES

II.A. Primary Objectives: To evaluate response rate (RR) and overall survival (OS).

II.B. Secondary Objective: To evaluate the time to progression (TTP), median time to response (MTR), toxicity and quality of life (QOL).

III. STUDY DESIGN:

III.A. Inclusion criteria:

1. Written informed consent. 2. Age between 18 and 70 years. 3. Documented by at least 2 out of three mentioned criteria and evidence of non-resectability.

1. Radiological either CT Scan/US abdomen
2. Biopsy,
3. Serum alphafeto protein level 4. Multi centric hepatoma or TNM Classification Stage IV. 5. Child's class B or C with a Child's score of maximum 11. 6. No other active malignancy except localized basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

   7. Life expectancy of greater then 3 months. 8. Current laboratory values must be within the limits listed below: Haemoglobin \> 8 g/dL WBC \> 4,000/uL Absolute Neutrophil Count \> 1,500/uL Platelets \> 75,000/uL 9. ECOG Performance status of \< 2. 10. Patients who have received adjuvant or neoadjuvant therapy are eligible. A minimum interval of 4 weeks since last chemotherapy will be required.

   11. Prior radiotherapy will be allowed if it did not involve a site used to assess response and 4 weeks have elapsed since completion of radiotherapy.

   III.B. Exclusion criteria:

   1. History of allergic reaction to compound chemically related to CAP. 2. Concomitant or previous malignancies within five years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix. 3. Active, uncontrolled infection. . 5. Concurrent medical problems which could limit the life expectancy or the ability of the patient to receive chemotherapy.

   6. Mental condition that could limit the patient in comprehending the concept of clinical trial or complying with its requirements.

   7. Brain or leptomeningeal involvement. 8. Pre-existing neurotoxicity of \>=grade 2. 9. Concomitant radiotherapy, unless localised for bone pain control or palliation.

   10. Being of reproductive potential and not agreeing to practice an effective contraceptive method.

   11. Pregnancy or lactation. 12. Severe renal impairment with Creatinine clearance \<30ml/minute. 13. Documented Cardiomyopathy or severe coronary artery disease, or history of arrhythmias.

   IV. PATIENT REGISTRATION

   All patients entering this study must be registered by contacting:

   Drs. Kashif Anis/Zaigham Abbas -Research Co-ordinators The Aga Khan University Hospital, Dept of Medicine/ Medical Oncology. Stadium Road, P.O. Box: 3500, Karachi, 74800, Pakistan Tel (021) 493-0051

   V. THERAPY

   This is a Phase II trial studying chemotherapy with CAP in non-resectable HCC. Prior chemotherapy, radiation therapy, surgery is permitted. Staging is required with a CAT scan/Ultrasound of abdomen and bone scan if necessary. Pre study evaluation should include CBC, renal functions assessment, and liver function tests. Patients will require independent evaluation with medical oncologist/gastroenterologist prior to being included in the study. Chemotherapy would be given in cycles of 21 days. CAP would be given as oral tablets twice daily starting from day 1 to day 14. Medication with standard anti-emetics, which may include serotonin antagonist, may be used before administration of chemotherapy. Duration of chemotherapy administration would be determined by the patient's response. A patient who has progressive disease, is not able to tolerate chemotherapy and has unacceptable toxicity would be taken off the study. Patients, who have a response, will continue on chemotherapy till progression of disease or inability to tolerate chemotherapy is documented.

   VI. DOSE MODIFICATION

   Hematologic Toxicity:

   Chemotherapy will be held if ANC \< 1,500/uL, and/or platelet count is \< 50,000/uL. Treatment will resume when counts recover. Growth factors can be used in subsequent cycles if delay is secondary to neutropenia. If there is no recovery after 3 weeks of delay, the patient will be taken off the study.

   Renal dysfunction:

   Creatinine Clearance mL/min Dose \>50 100% 30-50 75% \<30 0%(no treatment is given)

   Elevated Liver Function Tests:

   In the event that bilirubin is elevated during the study, the next cycle will be delayed by a maximum of 2 weeks. (The following dose modification in the dose of capecitabine will be made if the AST and/or ALT and/or alkaline phosphatase levels are elevated:

   AST/ALT Alkaline Phosphatase Recommended dose (%) \> 1.5- \< 2.5 x normal \< 2.5 x normal 75% \> 2.5- \< 5 x normal \> 2.5- \< 5 x normal 50% \> 5 x normal \> 5 x normal Dose delay by a maximum of 2 weeks. If no recovery is noted; the patient should go off study.

   Cardio toxicity:

   Significant drop in left ventricular ejection fraction and/or clinical signs and symptoms of cardiac failure will result in discontinuation from the study.

   Dose Modification:

   Dose reduction is planned if significant (Grade III/IV) hematologic or non-hematologic toxicities are observed. CAP shall be reduced by 25% with grade III/IV toxicity occur. Patient should be taken off study if a life threatening complication occurs. All grade III/IV toxicities should be recorded in detail including the dates of onset and resolution/outcome. GI toxicity of grade II including severe diarrhea, nausea, vomiting and stomatitis, dose modification will be done as, it will be held for 1 week along with symptomatic treatment , if no improvement for 2 weeks then patient will be taken off the study.

   VII. SERIOUS ADVERSE EVENT REPORTING

   All serious events (as defined in Appendix E of protocol) must be reported, as soon as you are aware of them to:

   Drs. Kashif Anis/Zaigham Abbas , at the Aga Khan University Hospital VIII. EVALUATION

   Evaluation before Treatment:

   Patient should have evaluation by gastroenterology/oncology to determine eligibility.

   All Patients should have:

   Diagnosis of hepatoma with the help of Biopsy if possible, or by the help of CT Scan or Serum alpha fetoprotein level, fulfilling 2 out of 3 criteria.

   Complete history and physical examination. CBC, differential, platelet count, serum sodium, potassium, glucose, calcium, creatinine, bilirubin, alkaline phosphatase, AST, ALT ,alpha fetoprotein(AFP), prothrombin time PT and Serum Albumin.

   CT scan of the abdomen with contrast. Cardiac evaluation of LVEF CT scans and plain x-rays if clinically indicated.

   Evaluation during Chemotherapy:

   CBC, differential, platelets count, sodium, potassium, creatinine, glucose, bilirubin, alkaline phosphatase, AST/ALT.

   CBC should be repeated prior to every chemotherapy course.

   Re-evaluation of response after every 3 courses of chemotherapy would be done radio logically by repeating a CT scan/x rays as indicated by sites of disease involvement.

   Evaluation After chemotherapy:

   All patients will be followed thereafter cessation of chemotherapy due to progression of disease, every three to six months until a total of five years for evaluation of five-year disease free and overall survival.

   Evaluation of toxicity profile.

   This should be based either on the NCIC common toxicity criteria (attached at the end), or any other major toxicity criteria (e.g. NCI), and documented in the attached form.

Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)

Aga Khan University

Muhammad Kashif Anis

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hormones

A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.

A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

Medical Director

A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.

LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

Disclosure Office Europe

Behaviors and Mental Disorders

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Tacrolimus

Immunosuppressive Agents

Immunologic Factors

Calcineurin Inhibitors

Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.

Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Placebo

Central Contact

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months.

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.

Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.

Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.

Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.

Sr Manager Clinical Trial Registries

Serious Adverse Events possibly related to study drug were collected.

The only other Adverse Events collected were those associated with study drug dose changes.

Subjects who experienced an Adverse Event with the same preferred term multiple times were only counted once.

Total

Age Continuous

Sex: Female, Male

American Indian or Alaskan Native

Black or African American

White

Race/Ethnicity, Customized

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Senior Medical Director, Medical Affairs

A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with complete IIEF questionnaire data at 18 months are included in the calculation.

Erectile Function Domain Score Between Treated and Untreated Groups

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who achieved normal erectile function are included in the calculation.

Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who used any impotence medications were included in the calculation.

Percentage of Patients Considered Successful Responders to Impotence Medications

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who had a successful response to impotence medications were included in the calculations.

Time to Achieve Response to Impotence Medications

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Belinostat When Used With Standard of Care Chemotherapy for Untreated Non-small Cell Lung Cancer	NCT01090830	Non-Small-Cell ...	Belinostat, car...	18 Years -	Holy Cross Hospital, Florida
Safety and Efficacy of Belinostat When Used With Standard of Care Chemotherapy for Untreated Non-small Cell Lung Cancer	NCT01090830	Non-Small-Cell ...	Belinostat, car...	18 Years -	Holy Cross Hospital, Florida
TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms	NCT03503968	Safety Tolerability Feasibility Treatment Effic...	MDG1011 Investigator Ch...	18 Years -	Medigene AG
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma	NCT00281541	Melanoma	YM155	18 Years -	Astellas Pharma Inc
Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)	NCT00464295	Carcinoma, Hepa...	Capecitabine in...	18 Years -	Aga Khan University
A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy	NCT00257478	Prostate Cancer Cancer of Prost... Prostatic Cance... Cancer of the P...	YM155	18 Years -	Astellas Pharma Inc
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy	NCT00328588	Lung Cancer Cancer of Lung Cancer of the L... Non-Small Cell ... Carcinoma, Non-...	YM155	18 Years -	Astellas Pharma Inc
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy	NCT00106392	Erectile Dysfun... Prostate Cancer	Tacrolimus Placebo	- 65 Years	Astellas Pharma Inc
Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)	NCT00464295	Carcinoma, Hepa...	Capecitabine in...	18 Years -	Aga Khan University
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma	NCT00281541	Melanoma	YM155	18 Years -	Astellas Pharma Inc
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy	NCT00106392	Erectile Dysfun... Prostate Cancer	Tacrolimus Placebo	- 65 Years	Astellas Pharma Inc

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