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Sagopilone+ prednisone

Phase 2

Prostate Cancer | Small molecule | Oncology |Bayer AG|Last Updated: Apr 8, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

Sagopilone+ prednisone · 1 trial · 1 indication

Phase 2 1
NCT00350051ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate CancerProstate Cancer
COMPLETED53 Analytics
PHASE2COMPLETED
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
at least 28 days post day 21 of last cycle of treatment

Secondary Endpoints

Safety & Tolerability of ZK-Epo plus prednisone
until progression, unknown duration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Sagopilone (ZK 219477) + prednisoneDRUGChemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Must have evidence of confirmed metastatic prostate cancer * Serum testosterone must be less than 50 ng/mL * Disease must be progressing despite anti-androgen therapy * PSA level must be elevated * Additional criteria determined at screening visit Exclusion Criteria: * Any p...

Countries:United StatesArgentina
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Sagopilone+ prednisone

What is Sagopilone used for?

Sagopilone is an investigational small molecule being studied for the treatment of several cancers, including non-small cell lung cancer, small cell lung cancer, breast cancer, and prostate cancer. It has been evaluated in clinical trials for these oncology indications, though it remains in clinical development and is not approved.

Who makes Sagopilone?

Sagopilone is being developed by Bayer AG, a German pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company has sponsored clinical trials of Sagopilone in oncology indications.

What phase is Sagopilone in?

Sagopilone has completed Phase 2 clinical trials for non-small cell lung cancer and breast cancer, and Phase 1 trials for small cell lung cancer and other neoplasms. It is an investigational drug, meaning it has not been approved by regulatory authorities and remains in clinical development.

What clinical trials is Sagopilone in?

Sagopilone has been studied in several completed clinical trials. NCT00160069 was a Phase 2 trial in non-small cell lung cancer with 128 participants in Germany. NCT00313248 was a Phase 2 trial in breast cancer with 65 participants in the US and Canada. NCT00359359 was a Phase 1 trial combining Sagopilone with cisplatin in small cell lung cancer, and NCT00432302 was a Phase 1 mass balance study.

Is Sagopilone the same as other drugs?

Sagopilone is a distinct investigational agent developed by Bayer AG. No alternative names for Sagopilone have been reported. It is a small molecule chemotherapy agent being evaluated for its safety and efficacy in treating various solid tumors, including lung and breast cancers.