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Solid Tumors

Kidney/Renal Cancer

1

Disease Status and/or Stage Advanced or Metastatic
Protocol Title A Global, Multicenter, Open-Label, Single Agent, Two-Stage, Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects with Advanced Renal Cell Carcinoma
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Subjects must have histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy. Subjects must have measurable disease and have had 1-3 prior systemic treatments for advanced or metastatic disease.
Treatment Overview

Eligible subjects will receive open-label AMG 102 at 20 mg/kg by IV infusion once every 2 weeks. Subjects may receive study treatment for up to 12 months or until radiologically and/or clinically confirmed progression or unacceptable toxicity.

Lab assessments will be performed before each cycle. Imaging studies will be done at week 1, 9, and every 8 weeks thereafter.

AMG 102 pharmacokinetics analysis will be perfromed as well as analysis of anti-AMG 102 antibodies while receiving study treatment, at the end of treatment visit, the safety follow-up visit, and the end of study visit. There are 2 exploratory studies, which requires the subject to authorize release of slides from their archived tumor tissue and blood draws.

2

Disease Status and/or Stage Renal cell carcinoma
Protocol Title Eastern Cooperative Onocology Group (ECOG) 2805: A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma (RCC)
PI David Nanus, MD
Contact Stephanie Erichsen, RN
212-746-5430
Key Eligibility

Must have primary intact RCC, eligible for nephrectomy with curative intent. Tumors ≥ 4 cm AND/OR macroscopic fully resectable nodes AND/OR surgically resectable renal vein thrombus AND/OR surgically resectable inferior vena caval thrombus by radiologic criteria to be clinically ≥ pT1bNany (resectable) M0 disease.

No prior anti-cacner therapy is permitted in either the adjucant or neoadjuvant setting. This includes metastectomy for renal cell carcinoma, or radioation therapy to the renal bed.

Treatment Overview

Patients will be randomized to either: Arm A (sunitinib) or Arm B (sorafenib alone) or Arm C (placebo)

3

Disease Status and/or Stage Advanced, unresectable and/or metastatic
Protocol Title A Phase I/II Trial of BAY 43-9006 plus Gemcitabine and Capecitabine in the Treatment of Patients with Advanced Renal Cell Carcinoma
PI David Nanus, MD
Contact Stephanie Erichsen, RN
212-746-5430
Key Eligibility Must have received one prior immunotherapy based regimen

No prior chemotherapy or prior treatment with BAY 43-9006 and/or inhibitors of the MAPK or VEGF pathways
Treatment Overview Patients receive BAY 43-9006 days 1-21, Gemcitabine day 1 and 8, and Capecitabine days 1-14 of 21 day cycle

Patients should receive a minimum of 3 cycles of therapy. Patient may continue treatment until disease progression or unacceptable side effects.

4

Disease Status and/or Stage Metastatic or Advanced
Protocol Title A Phase I/II Study of Vorinostat in Combination with Isotretinoin in the Treatment of Patients with Advanced Renal Cell Carcinoma
PI David Nanus, MD
Contact Stephanie Erichsen, RN
212-746-5430
Key Eligibility Must have received and failed two or more prior regimens including chemotherapy, immunotherapy, biological agents and/or radiation therapy.
Treatment Overview Vorinostat and Isotretinion given days 3-5, 10-12, 17-19 and 24-26 of 28 day treatment cycle

Therapy length of 4 cycles (16 weeks). If patient responds eligible for additional cycles.

5

Disease Status and/or Stage Any Stage of Cancer
Protocol Title Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis
Treatment Overview

All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)
 
Last updated: July,30, 2008
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