Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors This study is closed to enrollment. Purpose The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors. Study Design:  Treatment, Open Label, Single Group Assignment   Study Official Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors Further study details as provided by Biogen Idec: Primary Outcome Measures: Safety and tolerability of BIIB021  Secondary Outcome Measures: PK and PD of BIIB021  Antitumor activity  Estimated Enrollment:   68 Study Start Date:   February 2008 Estimated Primary Completion Date:   September 2010 (Final data collection date for primary outcome measure)   Arms Assigned Interventions 1: Experimental BIIB021 Drug: BIIB021 Dosage, frequency (once daily or twice daily), and duration as specified in protocol Eligibility Ages Eligible for Study:   18 Years and older Genders Eligible for Study:   Both Accepts Healthy Volunteers:   No Criteria Inclusion Criteria: Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available. Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2 Exclusion Criteria: Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels. Subjects with known brain metastases Concurrent severe or uncontrolled medical disease (i.e., diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/or the Sponsor could compromise protocol objectives. Subjects with screening or baseline prolongation of QTc interval > 450 msec for males or > 470 msec for females. Myocardial infarction within past 12 months from time of enrollment in this study. History of arterial or venous thrombosis within past 6 months from time of enrollment in this study. Red blood cell (RBC) or platelet transfusion within 30 days of screening. Active symptomatic fungal, bacterial, and/or known viral infection Inflammatory gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis. Please refer to: www.biogenideconcology.com Please refer to the clinicaltrials.gov website for further details on the study: http://clinicaltrials.gov/ct2/show/NCT00618735 To contact Biogen, click here.

An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors This study is closed to enrollment. Purpose This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021. Study Design:  This randomized, open-label, crossover study is designed to assess the effect of food and antacid on the pharmacokinetics of BIIB021. This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design.   Further study details as provided by Biogen Idec: Primary Outcome Measures: The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors. Secondary objectives of this study in this study population are as follows: To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions. To evaluate the safety and tolerability of BIIB021. To evaluate the antitumor activity of BIIB021. To evaluate the effect of BIIB021 on pharmacodynamic biomarkers. Study Location:   Approximately 3 sites in the United States Number of Planned Subjects:   16 evaluable subjects with a minimum of 6 subjects from each sex Study Start Date:   November 2009 Estimated Primary Completion Date:   September 2010 Study Population This study will be conducted in subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available. Treatment groups: Subjects will be randomly assigned to 1 of the following sequences for Cycle 1 AB, CD (4 subjects) BA, CD (4 subjects) AB, DC (4 subjects) BA, DC (4 subjects) All fasting begins at least 10 hours before BIIB021 dosing. BIIB021 will be taken 30 minutes after the start of the high fat meal. Regimen A: BIIB021 100 mg plus a high fat meal Regimen B: BIIB021 100 mg fasted Regimen C: BIIB021 450 mg fasted plus antacid (ranitidine) Ranitidine 150 mg will be taken after the evening meal the evening before dosing with BIIB021 and 1 hour before BIIB021 dosing the morning of Regimen C. Regimen D: BIIB021 450 mg fasted without antacid. For Cycle 2 and beyond, all subjects will continue BIIB021 at 450 mg TIW fasted until the occurrence of unacceptable toxicity, disease progression, death, or withdrawal of consent. The 450 mg doses must be taken 3 times per week, with at least 1 day, but no more than 2 days, between doses. Eligibility Ages Eligible for Study:   18 Years and older Genders Eligible for Study:   Both Accepts Healthy Volunteers:   No Criteria Inclusion Criteria: Subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available. Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Medically able to tolerate a high fat meal and to fast as per protocol. Ability to take ranitidine as per protocol. Exclusion Criteria: Previous treatment with an HSP90 inhibitor. Use of antacids within 7 days of study day 1. Prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of BIIB021. History of gastrectomy or major surgery to small intestine. History of exocrine pancreatic insufficiency. Chronic diarrhea (excess of 2 to 3 stools/days above normal frequency). History of hepatitis B or C or HIV, central nervous system metastasis. Conditions that may predispose subjects to seizures. Please refer to: www.biogenideconcology.com Please refer to the clinicaltrials.gov website for further details on the study: http://www.clinicaltrials.gov/ct2/show/NCT01017198 To contact Biogen, click here.

An Open-Label, Dose-Escalation, Safety, Pharmacokenetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors This study is currently recruiting participants. Purpose Safety and Tolerability of BIIB028 Study Design:  Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study   Study Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors Further study details as provided by Biogen Idec: Primary Outcome Measures: Safety and Tolerability of BIIB028  Secondary Outcome Measures: PK and PD of BIIB028  Antitumor activity  Estimated Enrollment:   40 Study Start Date:   July 2008 Estimated Study Completion Date:   July 2010 Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure) Intervention Details: Drug: BIIB028 IV infusion administered twice weekly until disease progression or unacceptable toxicity Eligibility Ages Eligible for Study:   18 Years and older Genders Eligible for Study:   Both Accepts Healthy Volunteers:   No Criteria Inclusion Criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Age greater than or equal to 18 years at the time of informed consent. Subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available. Anticipated survival of at least 3 months in the opinion of the Investigator. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal hepatic and bone marrow function. Must utilize effective contraception.  Exclusion Criteria: Pregnant (positive pregnancy test) or nursing women Prior treatment with Hsp90 inhibitors at any time. Prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer). In addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels. Concurrent severe or uncontrolled other medical disease (i.e, diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/ or the Sponsor could compromise assessment of safety. Use of anticoagulants, except low dose warfarin. Please refer to: www.biogenideconcology.com Please refer to the clinicaltrials.gov website for further details on the study: http://clinicaltrials.gov/ct2/show/NCT00725933 To contact Biogen, click here.

A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors This study is currently recruiting participants. Purpose Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors. Study Design:  Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study   Study Official Title: A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory, Cripto-Positive Solid Tumors Further study details as provided by Biogen Idec: Primary Outcome Measures: To evaluate safety  To determine the maximum-tolerated dose (MTD)  Secondary Outcome Measures: To evaluate pharmacokinetics (PK)  To evaluate clinical activity  Estimated Enrollment:   55 Study Start Date:   June 2008 Estimated Study Completion Date:   March 2010 Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure) Intervention Details: Drug: BIIB015 IV infusion once every 3 weeks until disease progression or unacceptable toxicity Eligibility Ages Eligible for Study:   18 Years and older Genders Eligible for Study:   Both Accepts Healthy Volunteers:   No Criteria Inclusion Criteria: Age 18 years or older at the time of informed consent. Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists. ECOG Performance Status </= 2. Exclusion Criteria: History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease. New York Heart Association (NYHA) Grade II or greater congestive heart failure. History of myocardial infarction within 6 months prior to Day 1. Presence of >/= Grade 2 peripheral neuropathy. Known presence of central nervous system or brain metastases. Prior therapy with a conjugated or unconjugated maytansine derivative. Please refer to: www.biogenideconcology.com Please refer to the clinicaltrials.gov website for further details on the study: http://clinicaltrials.gov/ct2/show/NCT00674947 To contact Biogen, click here.

Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors This study is closed to enrollment. Purpose Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors. Study Design:  Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study   Study Official Title: A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors Further study details as provided by Biogen Idec: Primary Outcome Measures: To evaluate the safety and tolerability of BIIB022 Secondary Outcome Measures: To evaluate pharmacokinetics Estimated Enrollment:   40 Study Start Date:   January 2008 Estimated Study Completion Date:   January 2010 Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure) Intervention Details: Drug: BIIB022 IV infusion once every three weeks until disease progression or unacceptable toxicity Eligibility Ages Eligible for Study:   18 Years and older Genders Eligible for Study:   Both Accepts Healthy Volunteers:   No Criteria Inclusion Criteria: Age 18 years or older at the time of informed consent Relapsed or refractory solid tumors following standard therapy. ECOG Performance Status 0 or 1. Exclusion Criteria: History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening. History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure. Known central nervous system or brain metastases. Prior anti-IGF-1R therapy of any kind. Please refer to: www.biogenideconcology.com Please refer to the clinicaltrials.gov website for further details on the study: http://clinicaltrials.gov/ct2/show/NCT00555724 To contact Biogen, click here.