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TOCOSOL Paclitaxel

Phase 3

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

TOCOSOL Paclitaxel development status

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

TOCOSOL Paclitaxel target and mechanism

ModalitySmall molecule

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 for the treatment of bladder neoplasms and breast cancer. It is not approved and remains in clinical development.

What is TOCOSOL Paclitaxel used for in breast cancer?

TOCOSOL Paclitaxel was evaluated as initial treatment for metastatic breast cancer in a Phase 2 trial. The study enrolled 47 female patients aged 18 years and older in Russia and has been completed. The drug is investigational and has not been approved for any indication.

Who is developing TOCOSOL Paclitaxel?

TOCOSOL Paclitaxel is being developed by Achieve Life Sciences, Inc., which trades under the ticker ACHV. The company is the sponsor of the clinical program for this investigational oncology asset.

What phase is TOCOSOL Paclitaxel in?

TOCOSOL Paclitaxel is in Phase 2 development. It has completed Phase 2 trials in metastatic breast cancer and in transitional cell carcinoma of the urothelium. There are currently no active trials, and the drug is not FDA approved.

What clinical trials is TOCOSOL Paclitaxel in?

TOCOSOL Paclitaxel has been studied in two completed Phase 2 trials: NCT00096668 in metastatic breast cancer, which enrolled 47 patients, and NCT00077688 in metastatic or locally advanced transitional cell carcinoma of the urothelium, which enrolled 44 patients. Both trials are completed.

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

Yes, TOCOSOL Paclitaxel and TOCOSOL(R) Paclitaxel refer to the same investigational drug. TOCOSOL(R) is the registered trademark form of the name used in trial titles and documentation. Both names describe the same oncology asset developed by Achieve Life Sciences, Inc.