Phase I

BAX69

Description:

BAX69 is an anti-macrophage migration inhibitory factor (anti-MIF) antibody. MIF is a pro-inflammatory cytokine that is up-regulated in many human cancers and contributes to growth, angiogenesis and migration of cancer cells. BAX69 is administered intravenously every 2 weeks in a 28 day cycle in patients with malignant solid tumors.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

BGJ398+BYL719

Description:

BGJ398 is an orally bioavailable inhibitor of human fibroblast growth factor receptor (FGFRs) with potential antiangiogenic and antineoplastic activities. BYL719 is an oral selective PI3K a isoform inhibitor. In this Phase I study BGJ398 in combination with BYL719 is administered in patients with select solid tumors that have PIK3CA gene mutation with or without FGFR genetic alteration.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Cabazitaxel

Description:

Cabazitaxel is a new taxoid, which promotes tubulin assembly and has shown strong antitumor activity against a broad spectrum of tumor models including those sensitive as well as resistant or refractory to other taxanes such as docetaxel. This is a Phase I safety and pharmacokinetic study of XRP6258 (Cabazitaxel) in advanced solid tumor patients with varying degrees of hepatic impairment.


Study Phase(s): Phase I
Category: Organ Dysfunction
Contact: Epp Goodwin at (210) 450-5798

Carfilzomib

Description:

Carfilzomib is a selective proteasome inhibitor. This Phase I study is evaluating the safety of Carfilzomib in patients with advanced solid tumors or hematological malignancies and varying degrees of hepatic impairment. It is administered on days 1, 2, 8, 9, 15, and 16 during a 28 day cycle.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

CBL0137

Description:

CBL0137 is a small molecule in the carbazole family affecting p53 and NF-kappa B signal transduction pathways. It is administered intravenously on days 1, 8 and 15 every 28 days in patients with metastatic or advanced solid tumors and refractory lymphomas.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Category: Solid Tumors/Non-Hematological
Contact: Epp Goodwin at (210) 450-5798

Crizotinib

Description:

Crizotinib is orally bioavailable ALK and c-MET/HGFR receptor tyrosine kinases inhibitor. This Phase I study evaluates the effect of hepatic impairment on the pharmacokinetics and safety of Crizotinib in advanced cancer patients with solid tumors.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

CZ48

Description: CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is an alkaloid extracted from the Chinese tree. CZ48 is administered orally every day in patients with advanced solid tumors or lymphomas.
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

GSK2118436

Description:

GSK2118436 is an orally bioavailbale inhibitor of B-raf protein which may inhibit the proliferation of tumor cells with mutated BRAF gene. It is administered in patients with V600 BRAF mutation positive tumors. Previous exposure to BRAF inhibitors is allowed.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Halaven

Description:

Halaven is a synthetic analogue of the marine spong natural product halichondrinB. As an inhibitor of microtubules it blocks the cell division and leads to apoptosis of the cancer cells. In this study Halaven is administered on days 1 and 8 of a 21 day cycle in patients with solid tumors who also have impaired renal function.


Type(s) of Cancer: Organ Dysfunction
Study Phase(s): Phase I
Category: Organ Dysfunction
Contact: Epp Goodwin at (210) 450-5798

IMGN 529

Description:

IMGN 529 consists of CD37 targeting humanized monoclonal antibody and cytotoxic maytansinoid DM1. In this Phase I study IMGN529 is administered intravenously every 3 weeks to patients with relapsed or refractory Non-Hodgkin’s lymphoma.


Type(s) of Cancer: Lymphoma
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

IMGN853

Description:

IMGN853 is an immunoconjugate consisting of the humanized monoclonal antibody against folate receptor 1 (FOLR1) conjugated to the cytotoxic maytansinoid DM4. It is administered once every 21 days intravenously in patients with advanced solid tumors with FOLR1 expression. Tumor types which have a high incidence of FOLR1 positivity (serous or endometroid epithelial ovarian cancer, serous endometrial cancer, NSCLC of adenocarcinoma and bronchoalveolar cancer and clear cell renal carcinoma) can enroll without the specific testing.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

LDE225

Description:

LDE225 is an oral selective Smo antagonist that downregulates the Hedgehog signal transduction pathway. In this Phase I study the patients with advanced solid tumors receive LDE225 with Warfarin or Bupropion to evaluate the drug-drug interaction.


Type(s) of Cancer: Any Solid Tumor
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

M402

Description:

M402 is a heparin sulfate mimetic designed to have antitumor effect without the anticoagulant activity. In this Phase I/II study M402 is administered as daily subcutaneous injection with Gemcitabine in patients with metastatic pancreatic cancer who have not received prior chemotherapy.


Type(s) of Cancer: Pancreas
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

Roflumilast

Description: Roflumilast is a selective long-acting inhibitor of the enzyme PDE-4 with anti-inflammatory effect. This enzyme is also shown to be overexpressed in refractory tumors. In this Phase O/I study Roflumilast is administered orally alone and in combination with Prednisone to patients with relapsed or refractory B-cell lymphoid malignancies.
Type(s) of Cancer: Lymphoma
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798

RTOG 0913

Description:

Description: This is a Phase I/II study of RAD001 (everolimus) for patients with glioblastoma or gliosarcoma (brain tumor). Patients are randomized to receive RAD 001 with the standard treatment of radiation plus temozolomide (oral chemotherapy) or to receive the standard treatment of radiation plus temozolomide alone.


Type(s) of Cancer: Brain
Study Phase(s): Phase I
Contact: Carol Jenkins at (210) 450-5924

VB-111

Description: VB-111 is a gene therapy against tumor blood vessels. It consists of a modified cold virus (Adenovirus) which delivers an endothelial angiogenic-specific promoter and a pro-apoptotic Fas Chimera transgene. It targets the growing blood vessels within the tumor to cause their destruction. VB-111 is administered as a single intravenous infusion in patients with glioblastoma multiforme who have disease progression or recurrence following standard of care treatment with Temozolomide and radiation.
Type(s) of Cancer: Brain
Study Phase(s): Phase I
Contact: Epp Goodwin at (210) 450-5798