DEPARTMENT OF MEDICINE
DIVISION OF HEMATOLOGY/ONCOLOGY
CLINICAL TRIALS STATUS REPORT

Amgen 20050136; IRB # 020613:
A randomized, double-blind, multicenter study of denosumab compared with zoledronic acid (ZometaÒ) in the treatment of bone metastases in subjects with advanced breast cancer.
PI: Dr Robert Siegel
Status: Open.

Amgen 20050244; IRB # 080612:
A randomized, double-blind, multicenter study of denosumab compared with zoledronic acid (ZometaÒ) in the treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma.
PI: Dr Imad Tabbara
Status: Not yet open. Pending contract and IRB approval.

 Amgen 20050159; IRB # 090652:
An open label, sequential cohort, dose escalation study to evaluate the safety and    efficacy of AMG 531 in thrombocytopenic subjects with low or intermediate-1 risk myelodysplastic syndrome (MDS).
PI: Dr Robert Siegel
Status: Open.

Genentech OSI 3364g “Beta Lung” IRB # 050511:
A phase III, multicenter, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy of bevacizumab in combination with tarceva (Erlotinib) compared with tarceva alone for treatment of advanced non-small cell lung cancer (NSCLC) after failure of standard first-line chemotherapy.
PI: Dr Imad Tabbara
Status: Open

Genentech AVF 3694g “RIBBON”; IRB # 010609:
A multicenter, phase III, randomized, placebo-controlled trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy regimens in subjects with previously untreated metastatic breast cancer.
PI: Dr Robert Siegel
Status: Open

Eastern Cooperative Oncology Group (ECOG) E2104; IRB # 110531:
Phase II feasibility trial incorporating bevacizumab into dose dense doxorubicin and  cyclophosphamide followed by paclitaxel in patients with lymph node positive brease cancer.
PI: Dr Robert Siegel
Status: Closed to enrollment.

For more information please contact: The Hemotology/Oncology Department at 202-741-2478