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S-8184 Paclitaxel Injectable Emulsion

Phase 2

Carcinoma, Non-Small-Cell Lung | 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 Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

S-8184 Paclitaxel Injectable Emulsion · 4 trials · 4 indications

Phase 2 4
NCT00034164Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung CancerCarcinoma, Non-Small-Cell Lung
COMPLETED52 Analytics
NCT00034177Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the UrotheliumUrologic Neoplasms
COMPLETED27 Analytics
NCT00034151Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian CancerOvarian Cancer
COMPLETED52 Analytics
NCT00034190Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal AdenocarcinomaColorectal Adenocarcinoma
COMPLETED28 Analytics
PHASE2COMPLETED
Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer
Carcinoma, Non-Small-Cell LungUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
Urologic NeoplasmsUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma
Colorectal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the objective response rate
After all patients completed therapy
Objective response rate; time to disease progression; duration of response; survival; toxicities
After all patients completed treatment
Determine the objective and partial response rates
No time frame-based on number of patients
Determine the Objective Response Rate
When all patients have completed treatment

Secondary Endpoints

To determine time to disease progression
After all patients completed therapy
Time to progression, duration of response and duration of survival
Based on number of patients
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
S-8184 Paclitaxel Injectable EmulsionDRUG -
Experimental Arm: TOCOSOL PaclitaxelDRUGDoses of 80, 100 and 120mg/m2
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Histologic diagnosis of non small cell lung cancer Relapsed or unresectable stage IIIB or IV disease One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent dosed at 60 mg/m2 or higher per cycle for cisplatin and AUC 6 per cycle for carb...

Countries:Russia
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Frequently asked questions about S-8184 Paclitaxel Injectable Emulsion

What is S-8184 Paclitaxel Injectable Emulsion used for?

S-8184 Paclitaxel Injectable Emulsion is an investigational small molecule oncology drug being studied for the treatment of ovarian cancer, non-small-cell lung cancer, urologic neoplasms, and colorectal adenocarcinoma. It has been evaluated in Phase 2 clinical trials for these indications.

Who is developing S-8184 Paclitaxel Injectable Emulsion?

S-8184 Paclitaxel Injectable Emulsion is being developed by Achieve Life Sciences, Inc., a company traded on the NASDAQ under the ticker symbol ACHV.

What phase is S-8184 Paclitaxel Injectable Emulsion in?

S-8184 Paclitaxel Injectable Emulsion is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for the drug have been completed.

What clinical trials is S-8184 Paclitaxel Injectable Emulsion in?

S-8184 Paclitaxel Injectable Emulsion has been studied in four completed Phase 2 trials: NCT00034151 for ovarian cancer, NCT00034164 for non-small-cell lung cancer, NCT00034177 for urologic neoplasms, and NCT00034190 for colorectal adenocarcinoma.

Is S-8184 Paclitaxel Injectable Emulsion the same as paclitaxel?

S-8184 Paclitaxel Injectable Emulsion is a formulation of paclitaxel, a chemotherapy agent, delivered as an injectable emulsion. It is being studied as a treatment for multiple solid tumor types.