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DSTP3086S

Phase 1

Prostate Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Oct 4, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

DSTP3086S · 1 trial · 1 indication

Phase 1 1
NCT01283373A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate CancerProstate Cancer
COMPLETED84 Analytics
PHASE1COMPLETED
A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and nature of dose-limiting toxicities (DLTs)
Days 1-21

Secondary Endpoints

Area under the concentration-time curve
Up to 1 year
Maximum and minimum concentrations
Up to 1 year
Clearance
Up to 1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALDose escalation cohorts
BEXPERIMENTALDose expansion cohorts

Interventions

NameTypeDescription
DSTP3086SDRUGDSTP3086S administered intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Life expectancy of at least 12 weeks * Histologic documentation of adenocarcinoma of the prostate * Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrat...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about DSTP3086S

What is DSTP3086S used for?

DSTP3086S is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety and pharmacokinetics in patients with this condition.

Who makes DSTP3086S?

DSTP3086S is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology drug for prostate cancer. Roche is responsible for the development and clinical testing of DSTP3086S.

What phase is DSTP3086S in?

DSTP3086S is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is complete, and the drug remains under investigation for metastatic castration-resistant prostate cancer.

What clinical trials is DSTP3086S in?

DSTP3086S has one completed clinical trial, NCT01283373, which was a Phase 1 study of the safety and pharmacokinetics of escalating doses in patients with metastatic castration-resistant prostate cancer. The trial enrolled 84 participants in the United States and was a controlled, non-randomized study.

Is DSTP3086S FDA approved?

DSTP3086S is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for metastatic castration-resistant prostate cancer. The completed Phase 1 trial assessed safety and pharmacokinetics, but the drug has not received marketing approval.