Disease: Head and Neck
A Randomized Phase III Trial of Adjuvant Therapy comparing chemotherapy alone (Six Cycles of Docetaxel plus cyclophosphamide of four cycles of doxorubicin plus cyclophosphamide followed by weekly Paclitaxel) to chemotherapy plus Trastuzumab in Women with Node-Positive of High-Risk Node Negative HER2-Low invasive Breast Cancer.
Objective: The primary objective is to show that the addition of trastuzumab to chemotherapy (either TC [Groups 1A and 2A] or AC -> WP [Groups 1B and 2B]) improves IDFS. Patients will be entered in one of these two chemotherapy cohorts based on the investigators preference, which must be indicated prior to randomization.
Phase Ib / II study of BAY 1000394 in combination with cisplatin / etoposide or carboplatin/etoposide as first-line therapy in subjects with extensive disease small cell lung caner.
Objective: The primary objective is to evaluate the response rate in subjects with extensive disease SCLC receiving first-line cisplatin / etoposide or carboplatin / etoposide chemotherapy in combination with BAY 1000394. Tumor response will be evaluated based on RECIST 1.1. Tumor measurements will be made at baseline and then every 2 cycles, ie every 6 weeks based on 21-day cycles, until progressive disease will occur.
A Phase 2 Study of Enzalutamide in patients with High-risk Prostate Cancer who have undergone local definitive therapy with Radical Prostatectomy.
Objective: The primary objective is to evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR).
Disease: Esophageal Head & Neck
A Phase II Trial of modified FOLFOX-6 Induction Chemotherapy followed by Esophagectomy and post-operative response based chemoradiotherapy in patients with locoregionally advanced adenocarcinoma of the esophagus, gastro-esophageal junction, and gastric cardia.
Objective: The primary objective is to assess the ability of response adapted adjuvant chemoradiotherapy to improve the 1 year RFS compared to historical data in patients with >50% remaining viable tumor after induction chemotherapy.
A phase 1b/2 study to evaluate the safety and efficacy of PF-04449913, an oral hedgehog inhibitor, in combination with intensive chemotherapy, low dose ara-c or decitabine in patients with AML or high-risk MDS.
Objective: The primary objective is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of PF-04449913 in combination with low dose Ara-C (LDAC; Arm A), decitabine (Arm B) or cytarabine/daunorubicin (Arm C) when administered to adults with previously untreated AML or high-risk MDS.
Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects with EphA3-Expressing Hematologic Malignancies.
Objective: The primary objective is to determine a possible maximum tolerated dose (MTD, defined in Section 7.1.1) for KB004 when administered up to 700 mg once weekly by IV infusion to subjects with hematologic malignancies.
A phase 1 trial of SGN-CD33A in patients with CD33-positive acute myeloid leukemia.
Objective: The primary objective is to evaluate the safety and tolerability of SGN-CD33A in patients with CD33-positive acute myeloid leukemia (AML) and to identify the maximum tolerated dose (MTD) of SGN-CD33A, if one exists at the doses tested.
Disease: Lung. NSCLC (Non-small cell lung cancer)
Phase I/II Study of MK-3475 (SCH900475) in Combination with Chemotherapy or Immunotherapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma.
Objective: The primary objective is to determine the recommended Phase II dose for MK-3475 in combination with chemotherapy or immunotherapy in subjects with unresectable or metastatic NSCLC.
Objective: The primary objective is to evaluate the efficacy of MPDL3280A in patients with locally advanced or metastatic UBC.
Photo by Russell Lee.