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ISIS EIF4E Rx

Phase 1

Castrate-Resistant Prostate Cancer | Small molecule | Oncology |Ionis Pharmaceuticals, Inc.|Last Updated: Oct 6, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

ISIS EIF4E Rx · 2 trials · 2 indications

Phase 1 2
NCT01234025Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC)Castrate-Resistant Prostate Cancer
COMPLETED113 Analytics
NCT01234038Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and PaclitaxelNon-small Cell Lung Cancer
COMPLETED116 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC)
Castrate-Resistant Prostate CancerUnlock trial analytics
PHASE1COMPLETED
Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival
At the end of each 21 day cycle
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 Cohort 1EXPERIMENTAL -
Part 1 Cohort 2EXPERIMENTAL -
Part 2 Arm AEXPERIMENTAL -
Part 2 Arm BEXPERIMENTAL -

Interventions

NameTypeDescription
ISIS EIF4E RxDRUG800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
PrednisoneDRUG5 mg administered orally twice daily on days 1, 8, 15 and 22 of each cycle
DocetaxelDRUG75 mg/m2 administered as a 1-hour intravenous infusion on day 1 of each cycle
PaclitaxelDRUG200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle
CarboplatinDRUGAUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Provide written informed consent prior to Screening. * Age ≥ 18 years. * Histological or cytological diagnosis of adenocarcinoma of the prostate. * Metastatic disease for which no curative therapy exists and for which systemic chemotherapy is indicated. * Progression of diseas...

Countries:United StatesHungaryPolandPuerto RicoRomaniaRussia
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Frequently asked questions about ISIS EIF4E Rx

What is ISIS EIF4E Rx used for?

ISIS EIF4E Rx is an investigational small molecule being studied for the treatment of castrate-resistant prostate cancer and non-small cell lung cancer. It is in Phase 1 clinical development and is not approved by the FDA.

Who makes ISIS EIF4E Rx?

ISIS EIF4E Rx is being developed by Ionis Pharmaceuticals, Inc., which trades under the ticker symbol IONS on the NASDAQ.

What phase is ISIS EIF4E Rx in?

ISIS EIF4E Rx is in Phase 1 clinical development. It has completed two Phase 1 trials, one in castrate-resistant prostate cancer and one in non-small cell lung cancer, and remains investigational.

What clinical trials is ISIS EIF4E Rx in?

ISIS EIF4E Rx has been studied in two completed Phase 1 trials. NCT01234025 evaluated it in combination with docetaxel and prednisone in castrate-resistant prostate cancer, and NCT01234038 evaluated it with carboplatin and paclitaxel in non-small cell lung cancer.

Is ISIS EIF4E Rx the same as any other drug?

No alternative names for ISIS EIF4E Rx have been reported. It is referred to by this name in clinical trial records and is distinct from other investigational agents.