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S-8184 Paclitaxel Injectable Emulsion

Phase 2

Carcinoma, Non-Small-Cell Lung | Small Molecules | Oncology |Achieve Life Sciences, Inc.|Trials Updated: Jun 4, 2009

S-8184 Paclitaxel Injectable Emulsion development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Apr 2002

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials4
Total Enrollment159

FDA Designations

No designations recorded

S-8184 Paclitaxel Injectable Emulsion clinical trials

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?

S-8184 Paclitaxel Injectable Emulsion is an investigational small-molecule oncology drug developed by Achieve Life Sciences, Inc. It is a formulation of paclitaxel delivered as an injectable emulsion and has been studied in Phase 2 trials across several solid tumor types, including non-small-cell lung cancer, colorectal adenocarcinoma, ovarian cancer, and urologic neoplasms.

What is S-8184 Paclitaxel Injectable Emulsion used for?

S-8184 Paclitaxel Injectable Emulsion has been studied for second-line treatment of several advanced cancers: stage IIIB or IV non-small-cell lung cancer, stage III or IV colorectal adenocarcinoma, stage III or IV ovarian cancer, and transitional cell carcinoma of the urothelium. These were Phase 2 investigations; the drug is not established as an approved therapy.

Who is developing S-8184 Paclitaxel Injectable Emulsion?

S-8184 Paclitaxel Injectable Emulsion is developed by Achieve Life Sciences, Inc., which trades under the ticker QUIT. The company sponsored the Phase 2 clinical program evaluating the agent in non-small-cell lung cancer, colorectal adenocarcinoma, ovarian cancer, and urologic neoplasms.

What phase is S-8184 Paclitaxel Injectable Emulsion in?

S-8184 Paclitaxel Injectable Emulsion is in Phase 2 development. Its clinical program consists of completed Phase 2 safety and efficacy trials in non-small-cell lung cancer, colorectal adenocarcinoma, ovarian cancer, and transitional cell carcinoma of the urothelium. The drug remains investigational and is not an approved product.

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

S-8184 Paclitaxel Injectable Emulsion has been evaluated in completed Phase 2 trials: NCT00034190 in second-line colorectal adenocarcinoma, NCT00034177 in transitional cell carcinoma of the urothelium, NCT00034164 in relapsed stage IIIB or IV non-small-cell lung cancer, and NCT00034151 in stage III or IV ovarian cancer. All were single-arm studies.

How was S-8184 Paclitaxel Injectable Emulsion studied in clinical trials?

S-8184 Paclitaxel Injectable Emulsion was studied in four completed Phase 2 trials, each an uncontrolled, non-randomized design enrolling adults aged 18 and older. The ovarian cancer trial enrolled women only. Trial sizes ranged from 27 to 52 participants, and the non-small-cell lung and colorectal studies were conducted in Russia.