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TOCOSOL Paclitaxel

Phase 3

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

TOCOSOL Paclitaxel development status

Highest phase Phase 3 (NCT00251095)
Phase scored for QUITPhase 2
Registered trials 2 across 1 sponsor since Feb 2004

TOCOSOL Paclitaxel target and mechanism

ModalitySmall Molecules

Also known as TOCOSOL(R) Paclitaxel

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment91

FDA Designations

No designations recorded

TOCOSOL Paclitaxel clinical trials

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?

TOCOSOL Paclitaxel is an investigational small-molecule oncology drug developed by Achieve Life Sciences, Inc. It has been studied in Phase 2 clinical trials as a treatment for breast cancer and for bladder neoplasms, including transitional cell carcinoma of the urothelium. It is also known as TOCOSOL(R) Paclitaxel.

What is TOCOSOL Paclitaxel used for?

TOCOSOL Paclitaxel has been studied in Phase 2 trials for metastatic breast cancer as initial treatment and for metastatic or locally advanced unresectable transitional cell carcinoma of the urothelium, a form of bladder cancer. It is investigational and has not been established as an approved therapy for these indications.

Who is developing TOCOSOL Paclitaxel?

TOCOSOL Paclitaxel is developed by Achieve Life Sciences, Inc., which trades under the ticker QUIT. The company sponsored the Phase 2 clinical program evaluating the drug in breast cancer and urothelial cancer.

What phase is TOCOSOL Paclitaxel in?

TOCOSOL Paclitaxel is in Phase 2 development. Its clinical program includes completed Phase 2 trials in metastatic breast cancer and in transitional cell carcinoma of the urothelium. The drug is investigational and is not approved for marketing in these indications.

What clinical trials is TOCOSOL Paclitaxel in?

TOCOSOL Paclitaxel has been evaluated in two completed Phase 2 trials. NCT00096668 studied it as initial treatment for metastatic breast cancer in 47 patients in Russia. NCT00077688 studied it in metastatic or locally advanced unresectable transitional cell carcinoma of the urothelium in 44 patients in the United States.

Is TOCOSOL Paclitaxel the same as TOCOSOL(R) Paclitaxel?

Yes, TOCOSOL(R) Paclitaxel is the same drug as TOCOSOL Paclitaxel. The registered trademark symbol appears in the formal name used in some trial titles and company materials, while TOCOSOL Paclitaxel is the shorter form used in general references to the same investigational oncology asset.