Clinical Research Unit Trials

                                                                                                 Click on trial for description and contact information.

Learn about the Minority-Based Community Clinical Oncology Program trials.

Advanced Solid Malignancies

• A Phase I Dose-Escalation, Multi-Center, Open-Label Study of AUY922 Administered I.V. on a Once-Weekly Schedule in Adult Patients with Advanced Solid Malignancies Including Phase II Expansion Arms in Patients with either HER2-Positive or ER-Positive Locally Advanced or Metastatic Breast Cancer



• A Phase I Dose-Finding Study of the Anti-Angiogenesis Agent AG-013736, in Combinations of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, and Gemcitabine/Cisplatin in Patients with Advanced Solid Tumors (This study is ongoing but currently not recruiting patients.)
  



• A Phase I Open-Label, Multi-Center, Parallel Group Study to Assess the Pharmacokinetics and Safety of Subcutaneous Azacitidine in Adult Cancer Patients with and without Impaired Renal Function


• FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-small Cell Lung Cancer


• A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer   NEW


• A Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) when administered to Patients with Advanced Solid Tumors (This study is ongoing but currently not recruiting patients.)

Breast Cancer

• Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-Cyclophosphamide in Patients With Locally Advanced Breast Cancer   NEW
  
  

• A Phase I/II Study of R115777 (Tipifarnib, Zarnestra) plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients with Stage IIB-IIIC Breast Cancer (This study is on-going but is no longer recruiting participants.)

• A Phase II Randomized, Double-Blind, Multi-Center Study of Exemestane with and without SNDX-275 in Postmenopausal Women with Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer, Progressing on Treatment with a Non-Steroidal Aromatase Inhibitor

• A Phase II Two-Arm, Double-Blind, Multi-Center, Randomized Study of the Combination of Oral WX-671 plus Capecitabine vs. Capecitabine Monotherapy in First-Line HER2-Negative Metastatic Breast Cancer (This study is on-going but is no longer recruiting participants.)

• A Phase I Dose-Escalation, Multi-Center, Open-Label Study of AUY922 Administered IV on a Once-Weekly Schedule in Adult Patients with Advanced Solid Malignancies Including Phase II Expansion Arms in Patients with Either HER2-Positive or ER-Positive Locally Advanced or Metastatic Breast Cancer

• A Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) when administered to Patients with Advanced Solid Tumor

Skin Cancer

• A Phase I/II Open-Label, Randomized, Three-Arm, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RAF265 (CHIR-265) Administered Orally to Patients with Locally Advanced or Metastatic Melanoma (This study is on-going but is no longer recruiting participants.)
  

Gastrointestinal Cancer

• A Phase 2, Randomized, Double-Blind, Placebo Controlled Study of AMG 386 in Combination with FOLFIRI in Subjects with Previously Treated Metastatic Colorectal Carcinoma

• A Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) when administered to Patients with Advanced Solid Tumors
  

Genitourinary / Prostate Cancer

• A Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) when administered to Patients with Advanced Solid Tumors

Gynecologic Malignancies

• A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer


• A Phase II Single Arm Study of Carboplatin and DOXIL (PLD) Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers


• A Phase II Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma (This study is ongoing, but currently not recruiting patients.)


• A Phase II Evaluation of Gemcitabine (Gemzar®, LY188011) in the Treatment of Recurrent or Persistent Endometrial Carcinoma (This study is ongoing, but currently not recruiting patients.)


• Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer


• A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer


• A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients With Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


• A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum


• Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer (This study is ongoing but currently not recruiting patients.)


• A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer (This study is ongoing, but currently not recruiting patients.)


• A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus (This study is ongoing, but currently not recruiting patients.)


• A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas (This study is ongoing, but currently not recruiting patients.)


• Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer


• A Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) when administered to Patients with Advanced Solid Tumors
  

Hematologic Malignancies

• Safety and Efficacy of Panobinostat in Primary Myelofibrosis  NEW


• Aggressive Systemic Mastocytosis or Mast Cell Leukemia


• Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma (This study is ongoing, but currently not recruiting patients.)


• A Phase IA/II Two-Arm, Multi-Center, Open-Label, Dose-Escalation Study of LBH589 Administered Orally via Different Dosing Schedules in Adult Patients with Advanced Hematological Malignancies (This study is ongoing but currently not recruiting patients.)


• A Phase 2, multi-center, open-label, exploratory study of Bcr-Abl kinetics in adult patients on nilotinib with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) and a suboptimal molecular response to imatinib

 

• A single arm, phase II, open-label study to determine the efficacy of 100mg twice daily oral dosing of Midostaurin administered to patients with Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease

 

• A Phase I Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of SNX-5422 Mesylate in Subjects with Refractory Hematological Malignancies

 

• A Phase I Open-Label, Multi-Center, Parallel Group Study to Assess the Pharmacokinetics and Safety of Subcutaneous Azacitidine in Adult Cancer Patients with and without Impaired Renal Function
  
  

Thoracic Cancer

• A Phase I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and/or Refractory Stage IIIB (with Malignant Pleural or Pericardial Effusion), or Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients (This study is ongoing but currently not recruiting patients.)


• A Phase I/II Study of Anti-Tumor Vaccination Using a(1,3) Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients with Refractory or Recurrent Non-Small Cell Lung Cancer (This study is ongoing, but currently not recruiting patients.)


• A Phase I Dose-Finding Study of the Anti-Angiogenesis Agent AG-013736, in Combinations of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, and Gemcitabine/Cisplatin in Patients with Advanced Solid Tumors


• FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective
  Validation in Non-small Cell Lung Cancer 

 

• A Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) when administered to Patients with Advanced Solid Tumors

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