Recent Updates
Recently added Catalysts

Sagopilone+ carboplatin

Phase 2

Ovarian Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Apr 8, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Sagopilone+ carboplatin · 2 trials · 1 indication

Phase 2 2
NCT00325351ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian CancerOvarian Neoplasms
COMPLETED45 Analytics
NCT00246688Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian CancerOvarian Neoplasms
COMPLETED63 Analytics
PHASE2COMPLETED
ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer
Ovarian NeoplasmsUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer
Ovarian NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Response to treatment with ZK-Epo after 6 cycles
After 6 cycles
Proportion of responders
18 weeks

Secondary Endpoints

Safety and tolerability of ZK-Epo given with carboplatin
Sept. 2008
Duration of response
up to 1 year after LPLTV
Time to disease progression
up to 1 year after LPLTV
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Sagopilone, 0.5 h infusionEXPERIMENTALSubjects received one infusion (for 0.5 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks
Sagopilone, 3 h infusionEXPERIMENTALSubjects received one infusion (for 3 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Interventions

NameTypeDescription
Sagopilone (ZK 219477) + carboplatinDRUGChemotherapy for recurrent ovarian cancer
Sagopilone (BAY86-5302 , ZK219477)DRUG10.5 mg lyophilized sagopilone per vial
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria:- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cispla...

Countries:United StatesCanada
Unlock Eligibility Criteria

Frequently asked questions about Sagopilone+ carboplatin

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.