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Custirsen, paclitaxel and carboplatin

Phase 1

Cancer | Small molecule | Oncology |Achieve Life Sciences, Inc.|Last Updated: Oct 10, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

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Clinical trial landscape

Custirsen, paclitaxel and carboplatin · 1 trial · 1 indication

Phase 1 1
NCT01497470A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment RegimenCancer
COMPLETED36 Analytics
PHASE1COMPLETED
A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen
Cancer
NCT0149747036
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Study Endpoints

Primary Endpoints

To evaluate the impact of custirsen on paclitaxel pharmacokinetics
0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion

The maximum peak concentration of paclitaxel after administration.

Secondary Endpoints

To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy
0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Paclitaxel/carboplatin with custirsenEXPERIMENTALCustirsen added to standard paclitaxel/carboplatin chemotherapy

Interventions

NameTypeDescription
Custirsen, paclitaxel and carboplatinDRUGCustirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Confirmed diagnosis of a solid tumor that is refractory to standard therapies and is not amenable to treatment with established curative or palliative therapies and for whom paclitaxel and carboplatin is deemed an acceptable treatment by the investigator * Males or females ≥18...

Countries:United States
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Competitive Landscape -Cancer 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Frequently asked questions about Custirsen, paclitaxel and carboplatin

What is Custirsen used for?

Custirsen is an investigational small molecule being studied for use in non-small cell lung cancer, prostate cancer, and cardiac conduction and repolarization. It has been evaluated in clinical trials for these conditions, though it remains in development and is not approved for any indication.

Who makes Custirsen?

Custirsen is being developed by Achieve Life Sciences, Inc., a company traded under the ticker symbol ACHV. The drug has been studied in multiple clinical trials sponsored by the company across various cancer and cardiac indications.

What phase is Custirsen in?

Custirsen has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. The most advanced trial was a Phase 3 study in prostate cancer, which has been completed. The drug is investigational and remains in clinical development.

What clinical trials is Custirsen in?

Custirsen has been evaluated in several completed trials, including NCT00138658 in non-small cell lung cancer, NCT00327340 in prostate cancer, NCT01188187 in prostate cancer, and NCT01874561 for cardiac repolarization. These trials have all been completed.

Is Custirsen the same as OGX-011?

Yes, Custirsen is also known as OGX-011. Clinical trials have used the name OGX-011 to refer to the same drug, including studies in non-small cell lung cancer and prostate cancer.

What does Custirsen target?

Custirsen is a small molecule that has been studied for its effects on cancer and cardiac conditions. The specific molecular target of Custirsen is not disclosed in the available information, so its mechanism of action is not described here.