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SHARP Clinical Oncology Research
2011

Protocols


Metastatic BREAST

TDM4370g/BO21977 - Randomized, Multicenter, Ph. III Open-label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 VS Capecitabine + Lapatinib in Patients with HER2-Positive locally Advanced or Met. Breast cancer who have Received Prior Trastuzumab Therapy. (EMILIA Study)

IMCL CP12-0606/TRIO - A Multicenter, Multinational, Randomized, Double-Blind, Ph. III Study of IMC-1121B Plus Docetaxel VS Placebo Plus Docetaxel in Previously Untreated Patients with Her2-Negative, Unresectable, Locacally-Recurrent or Metastatic Breast Cancer.

BO22589/B/TDM4788g - A randomized, 3 arm, multicenter, ph. III study to evaluate the Efficacy & Safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), vs the combination of trastuzumab plus taxane, as first line treatment in HER2-positive progressive or recurrent locally advanced or metastatic breast cancer (MBC).


HEPATOCELLULAR - Adjuvant

CA 182037 - A Randomized, Double-blind, Multicenter Ph.III Study of Brivanib vs. Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in patients with Unresectable HCC. (BRISK TA Study)


HEPATOCELLULAR - Advanced

CA182033 - A Randomized, Double-blind, Multi-center Ph. III Study of Brivanib vs. Sorafenib as First-line Treatment in Patients with Advanced Heapatocellular Carcinoma. (BRISK FL Study)

CA182034 - A Randomized, Double-blind, Multi-center Ph.III Study of Brivanib plus Best Supportive Care (BSC) vs. Placebo plus BSC with Adv. HCC who have failed or are Intolerant to Sorafenib. (BRISK PS Study)


LUNG - Adjuvant

MAGRIT 109493 - A Double-blind, randomized, placebo-controlled Ph. III study to assess the efficacy of rec MAGE-A3 +AS15 Antigen -specific Cancer Immunotherapy as adjuvant therapy in patients with respectable MAGE-A3 positive NSCLC.


LUNG - Metastatic

CA196005 - A Randomized Double-blinded Phase III Study of Carboplatin/Paclitaxel/CT-322 vs. Carboplatin/Paclitaxel/Bevacizumab as First Line Treatment for Recurrent or Advance NSCLC with Non-Squamous Histology.

CA225346 - Cisplatin and Vinorelbine in Combination with Cetuximab as First Line Treatment for Patients with Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study.

EFC11553 - Randomized Ph. 3 Trial of Gemcitabine/Carboplatin with or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects with Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer.


LEUKEMIA - CLL

BO21004 - An Open-label, multi-center, three arm randomized, Phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil )RClb) or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities.


Diffuse Large B-cell NHL

CO5013 - An Open-Label, Randomized, Phase s Study to Assess the Effectiveness of RCHOP with or without VELCADE in Previously Untreated Patients with Non-Germinal Center B-Cell-like Diffuse Large B-Cell lymphoma. (PYRAMID Study)


Indolent NHL

GAO4753g - An Open-label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine compared with Bendamustin+RO5072759 (GA101) in Patients with Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma.


MELANOMA - Metastatic

CA184045 - A Multicenter Treatment Protocol for Compassionate Use of Ipilimumab (BMS-734016) Monotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma.


PANCREATIC - Metastatic

TH-CR-404 - A Randomized Cross-over Phase 2 Study of the Safety and Efficacy of Two Dose Levels of T-302 in Combination with Gemcitabine Compared with Gemcitabine Alone in Previously Untreated patients with Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma.


PROSTATE - Metastatic

P07-2 - A Randomized, multicenter, single Blind Study in men with Metastatic Androgen Independent Prostate cancer to Evaluate Sipuleucel-T Manufactured with Different concentrations of PA2024 Antigen.

MDV3100-03 - A Multinational Phase 3 Randomized, Double-blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy Na´ve Patients with Progressive Metastatic Prostate Cancer who have Failed Androgen Deprivation Therapy. (PREVAIL Study)

212082PCR3001 - EAP - An Open Label Study of Abiraterone Acetate in subjects with Metastatic Castration-Resistant Prostate Cancer Who have Progressed After Taxane-Based Chemotherapy.


SOLID TUMORS

H4613g - A Phase 1b, Single-Arm, Open Label Clinical Trial to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the presence of Docetaxel in patients with HER2-positive Metastatic or Locally Advanced inoperable Cancer.

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