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GX15-070MS

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

GX15-070MS · 1 trial · 1 indication

Phase 1 1
NCT00600964A Phase I/II Study of GX15-070MS in Untreated CLLChronic Lymphocytic Leukemia
COMPLETED26 Analytics
PHASE1COMPLETED
A Phase I/II Study of GX15-070MS in Untreated CLL
Chronic Lymphocytic LeukemiaUnlock trial analytics

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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about GX15-070MS

What is GX15-070MS used for?

GX15-070MS is an investigational small molecule being studied for the treatment of chronic lymphocytic leukemia (CLL). It is in Phase 1 clinical development and has been evaluated in a completed clinical trial for patients with untreated CLL.

Who makes GX15-070MS?

GX15-070MS is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development for chronic lymphocytic leukemia.

What phase is GX15-070MS in?

GX15-070MS is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1/II study of the drug in chronic lymphocytic leukemia has been completed.

What clinical trials is GX15-070MS in?

GX15-070MS has been studied in clinical trial NCT00600964, titled 'A Phase I/II Study of GX15-070MS in Untreated CLL'. This trial was completed and enrolled 26 participants with chronic lymphocytic leukemia in the United States and Canada.

Is GX15-070MS FDA approved?

GX15-070MS is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for chronic lymphocytic leukemia. The drug has completed one clinical trial but remains under investigation and has not been approved for any use.