Recent Updates
Recently added Catalysts

GX15-070MS

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: May 12, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00600964A Phase I/II Study of GX15-070MS in Untreated CLLPHASE1 COMPLETED 26Sep 1, 2004Jan 1, 2006May 12, 20145 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
14 days
Secondary Endpoints
Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.
14 days
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GX15-070MSEXPERIMENTALGX15-070MS at various doses and schedules
Interventions
NameTypeDescription
GX15-070MSDRUGA 60-minute or 3-hour IV infusion every 2-3 weeks.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Histologically or cytologically confirmed B-CLL * Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1 * Age ≥18 ye...

Countries:United StatesCanada
Unlock Eligibility Criteria