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TOCOSOL Paclitaxel

Phase 2

Bladder Neoplasms | Small molecule | Oncology |Achieve Life Sciences, Inc.|Last Updated: Jun 4, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

TOCOSOL Paclitaxel · 2 trials · 5 indications

Phase 2 2
NCT00096668Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast CancerBreast Cancer
COMPLETED47 Analytics
NCT00077688TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the UrotheliumBladder Neoplasms
COMPLETED44 Analytics
PHASE2COMPLETED
Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer
Breast CancerUnlock trial analytics
PHASE2COMPLETED
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
Bladder NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Tolerability
After all patients complete treatment
Objective response rate

Secondary Endpoints

Objective Response Rate
After alll patients complete treatment
Time to treatment failure
Time to progression
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TOCOSOL PaclitaxelEXPERIMENTALTOCOSOL Paclitaxel administered weekly at 120mg/mm2

Interventions

NameTypeDescription
TOCOSOL(R) PaclitaxelDRUG -
TOCOSOL PaclitaxelDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Female patient with histologic diagnosis of breast carcinoma * Stage IV (M1) disease * No prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer * Adult (18 years of age or older) patients * Adequate hematologic function (ANC \>=1500 cells/mm3 and plate...

Countries:RussiaUnited States
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Frequently asked questions about TOCOSOL Paclitaxel

What is TOCOSOL Paclitaxel used for?

TOCOSOL Paclitaxel is an investigational small molecule being studied for the treatment of bladder neoplasms and breast cancer. It has been evaluated in clinical trials for metastatic or locally advanced unresectable transitional cell carcinoma of the urothelium and as initial treatment for metastatic breast cancer.

Who is developing TOCOSOL Paclitaxel?

TOCOSOL Paclitaxel is being developed by Achieve Life Sciences, Inc., a company traded on the NASDAQ under the ticker symbol ACHV. The drug is currently in Phase 2 clinical development for oncology indications.

What phase is TOCOSOL Paclitaxel in?

TOCOSOL Paclitaxel is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for this drug have been completed, and it remains under investigation for its safety and efficacy.

What clinical trials has TOCOSOL Paclitaxel been in?

TOCOSOL Paclitaxel has been studied in two completed Phase 2 trials. One trial, NCT00077688, enrolled 44 participants with bladder, ureteral, or urethral neoplasms and transitional cell carcinoma in the United States. Another trial, NCT00096668, enrolled 47 female participants with breast cancer in Russia.

Is TOCOSOL Paclitaxel the same as paclitaxel?

TOCOSOL Paclitaxel is a formulation of paclitaxel, a chemotherapy agent. It is being developed as a specific product by Achieve Life Sciences. The clinical trials listed for TOCOSOL Paclitaxel evaluate it as a treatment for bladder cancer and breast cancer.