Clinical trials are important for progress in all medical specialties. In oncology, a clinical trial is a research study specifically designed to answer a scientific question, usually to identify new and better ways to detect, treat or prevent cancer. Clinical trials are necessary to find out if new treatments are more effective than those currently accepted as the best available standard therapy.

CLINICAL TRIALS AT SEAROC CANCER CENTER

Principal Investigator – A phase 2, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of IP XXX in reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer.

Principal Investigator – A Prospective, Multicentric, Open-Label, Single Arm, Phase II Study To Assess Efficacy And Safety Of Daily Intravenous Administration of IP XXX Emulsion In Cancer Subjects With Febrile Neutropenia.

Principal Investigator – “A Randomized, Multicenter therapeutic confirmatory study to evaluate the efficacy and safety of IP XXX plus Best Supportive Care versus Best Supportive Care alone in patients with advanced squamous cell carcinoma of the head and neck who have received at least one anti-cancer treatment regimen for advanced disease”.

Principal Investigator – “A two way cross over experimental evaluation of relative bioavailability of two formulation of IP XXX capsule in adult human male and/or female patient under fasting conditions.”

Principal Investigator – “A Prospective, Non-Comparative, Open Label, Multicentre Study to Evaluate Safety and Efficacy of IP XXX For Prevention of Neutropenia in the Patients Receiving Cancer Chemotherapy.”

Principal Investigator – A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined with XXX to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer

Principal Investigator – To study safety and efficacy of IP XXX in patients with Chemotherapy induced neutropenia.

Sub Investigator – “A Phase III b, Randomized, Double blind, Parallel group, Multi Center Study to Assess the Efficacy and Safety of Multiple 30 Minute infusions of IP XXX in Subjects with Euvolemic or Hypervolemic Hyponatremia”

Principal Investigator – A Randomized Double-Blind Phase 3 study of XXX plus BSC vs Placebo plus BSC in subject with advanced hepatocellualr carcinoma who have failed or are intolerant to sorafenib.

Principal Investigator – “Phase III Randomized, Multi Center Study of IP XXX or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated”

Principal Investigator – A Randomized, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of IP XXX  ----mg with IP YYY -----mg in Postmenopausal Women with Estrogen Receptor Positive Advanced Breast cancer

Principal Investigator – An Open- Label Randomized Phase II Study of Two Different Dosing Regimens of Drug XXX in Combination with Intravenous drug YYY in Patients with Locally Advanced and/or Metastatic Breast Cancer

Principal Investigator – “An open labeled, non-comparative, Safety & Efficacy study of IP XXX in the treatment of chemotherapy-induced neutropenia”

Principal Investigator – “A Phase III Randomized, Double-blind Study to Assess the Efficacy and Safety of IP XXX versus Placebo in Patients with Hormone- resistant Prostate Cancer and Bone Metastasis who are Pain Free or Mildly Symptomatic.”

Principal Investigator – An open-label IP XXX continuation protocol for patients who have completed a prior IP XXX study and are judged by the investigator to have the potential to benefit from IP XXX treatment

Principal Investigator – “An open label, comparative, multicentric study to assess the efficacy and safety of IP XXX in comparison with Drug YYY for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.”

Principal Investigator – A Randomized, Double-Blind, Multicenter Study of IP XXX Compared with Drug YYY in the treatment of Bone Metastases in Men with Hormone Refractory Prostate Cancer

Principal Investigator – A Randomized, Double-Blind, Multicenter Study of IP XXX Compared with Drug YYY in the treatment of Bone Metastases in Subjects with Advanced Breast Cancer

Principal Investigator – A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of IP XXX in Combination with Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer”

Principal Investigator – A Randomized, Controlled Phase III Trial of IP XXX and Best Supportive Care (BSC) versus BSC Alone in Patients with Small Cell Lung Cancer (SCLC), Refractory or Progressive within Six Months of Completing First-Line, Platinum Containing Chemotherapy

Principal Investigator – “A Pivotal Trial to Determine the Efficacy and Safety of IP XXX when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas”.

Principal Investigator – “A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant IP XXX in Women with Early-Stage ErbB2 Over expressing Breast Cancer”

Principal Investigator – “IP XXX as second line therapy for Metastatic Renal Cell Cancer”

Principal Investigator – A Randomized Phase 3 Study of IP XXX in Combination with Cisplatin versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

Principal Investigator – “A Randomized Phase 2 Study Comparing IP XXX-YYY, YYY alone, and XXX alone, as Second-Line Treatment for Non- Smoker Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer”

Principal Investigator – “Phase 3 Study of IP XXX, Cisplatin, and Radiotherapy Followed by Consolidation IP XXX versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology”

Principal Investigator – “A Phase III Randomized, Double - blind, Placebo-controlled Study to Assess the Efficacy and Safety of IP XXX in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone- resistant Prostate Cancer”

Principal Investigator – “An Open-Label, Dose-Finding, Prospective, Multi-Center, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of Three Different Dose Levels of IP XXX Compared With a Standard Dose of Neupogen® in Breast Cancer Patients at High (>20%) Risk for Chemotherapy-Induced Severe Neutropenia”

Principal Investigator – “A multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IP XXX in the Prevention of Venous Thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy”.

Principal Investigator – “An open label, multicenter phase I study of IP XXX in subjects with advanced refractory malignancies”.

Sub Investigator – International, multi-center, randomized, double blind study to compare the overall morality in acutely ill medical patients treated with IP XXX versus placebo in addition to Graduated Elastic Stockings.

Principal Investigator – “An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of IP XXX in triple receptor negative breast cancer patients”.

Principal Investigator – “A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled IP XXX in Combination with Paclitaxel, or Open-Label IP YYY in Combination with Paclitaxel, as First Line Therapy in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer”.

Principal Investigator – “A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of IP XXX Versus Placebo Administered to Patients with Non-Small Cell Lung Cancer-Related Fatigue and Cachexia”.

Sub-Investigator – “A multinational, Multicenter, randomized, double blind study comparing the efficacy and safety of IP XXX with drug YYY for the prevention of venous thromboembolism in patients undergoing major abdominal surgery”.

Principal Investigator – “Phase 3b, Randomized, Open-Label Study of IP XXX + IP YYY vs. IP XXX + IP ZZZ as First-Line Treatment in Subjects with Advanced Renal Cell Carcinoma”.

Principal Investigator – “A Randomised, Double-Blind, Multicentre Phase II/III Study to Compare the Efficacy of IP XXX in combination with FOLFOX, to the Efficacy of IP YYY in Combination with FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer.”

Principal Investigator – “A Phase 3 Randomized, Open Label Study of IP XXX versus IP YYY in Subjects with Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia”.

Principal Investigator – “A Randomized, 4-Arm, Placebo controlled Phase II trial of IP XXX in combination with Bevacizumab and Paclitaxel or IP XXX plus Paclitaxel as first-line therapy in subjects with Her2-Negative, Metastatic or locally recurrent breast cancer”.

Principal Investigator – A Two – Way Crossover Experimental Evaluation of Relative Bioavailabilities Of Two Formulations Of Test IP XXX In Adult Human Male And/or Female Patients Under Fasting Conditions.

Principal Investigator – “A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous IP XXX for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy”.

Principal Investigator – “A Multicentre Phase I Study of IP XXX in Advanced Breast Cancer

Principal Investigator – Open-label Multi-center Safety Trial of IP XXX Spray for the treatment of Breakthrough Cancer pain.

Principal Investigator – A Phas III Randomized Double Blind study of IP XXX in combination with IP YYY compared with IP YYY combination with placebo for the treatment of subjects with relapsed or refractory follicular Non Hodgkin's Lmphoma

Principal Investigator – "Multicentre randomized double blind phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard docetaxel therapy compared to placebo plus standard docetaxel therapy in patients with stage IIIB/IV or recurrent NSCLC after failure of first line chemotherapy"

Principal Investigator – "A randoized double blind placebo controlled multicenter phase II IP XXX Dose range study to evaluate the safety and efficacy of IP XXX in patients with NSCLC"

Principal Investigator – “A Phase 1b / 2 Trial of IP XXX or IP YYY in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer”

Principal Investigator – "Registration phase III study of IP XXX in advanced NSCLC: An international multicenter randomized double blind placebo controlled study of IP XXX maintenance therapy for stage III/IV NSCLC subjects who have responded to or have stable disease following one regimen of front line platinum based combination chemotherapy" 

Principal Investigator – A phase 1/2 study of the vascular disrupting agent IP XXX in combination with Docetaxel in patients with Advanced NSCLC

Principal Investigator – "A Multicenter multinational phase III randomized study to evaluate the safety and efficacy pt treating colorectal cancer patients with recurrent Liver metastases using Novel System plus chemotherapy as compared to chemotherapy alone".

Principal Investigator – "A phase III study of XXX plus YYY versus YYY alone in patients with advanced breast cancer previously treated with resistant to an anthracycline and who are taxane resistant"

Principal Investigator – A Randomized Double-Blind Placebo controlled study to evaluate the long term safety & efficacy of XXX administration at 500mcg once every 3 weeks in anemic subjects with advanced stage non small cell cancer receiving multicycle Chemotherapy.

Principal Investigator – A Randomized Double-Blind Placebo controlled Phase III study to assess the safety & efficacy of weekly XXX in combination with carboplatin and taxane in subjects with platinum sensitive ovarian cancer in first relapse.

Principal Investigator – A phase III multicenter open lable study to evaluate the efficacy and the safety of drug XXX in chronic ITP.

Principal Investigator – An International, Randomized Double Blinded Phase III efficacy study of XXX versus Placebo in subjects with unresectable locally advanced or metastatic medullary thyroid cancer.