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Gimatecan

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

Gimatecan · 4 trials · 2 indications

Phase 1 4
NCT00487058A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED28 Analytics
NCT00441610An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid TumorAdvanced Solid Tumors
COMPLETED4 Analytics
NCT00410358A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.Advanced Solid Tumors
COMPLETED19 Analytics
NCT00420485Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid TumorsSolid Tumors
COMPLETED120 Analytics
PHASE1COMPLETED
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)
Safety and tolerability assessed by Adverse Events
2.8 years
Anti-tumor activity assessed by RECIST criteria
2.8 years
Estimated Maximum Tolerated Dose of gimatecan
1.8 years
Presence of dose limiting toxicities in a 56-day treatment period
56 days

Secondary Endpoints

Safety assessed by adverse events
1.8 years
Characterization of the pharmacokinetic profile of gimatecan
1.8 years
Anti-tumor activity assessed by RECIST
1.8 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GimatecanEXPERIMENTAL -
LBQ707EXPERIMENTAL -
Daily times five scheduleEXPERIMENTAL -
Continuous schedule, twice dailyEXPERIMENTAL -

Interventions

NameTypeDescription
GimatecanDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria * Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists * Life expectancy of at least 3 months * No dysfunction of bone marrow * No major impairment of renal and hepatic function...

Countries:JapanCanadaDenmarkFranceGermanyNetherlandsNorwaySpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about Gimatecan

What is Gimatecan used for?

Gimatecan is an investigational small molecule being studied for the treatment of solid tumors and advanced solid tumors. It is in Phase 1 clinical development and has not been approved by regulatory authorities. Clinical trials have evaluated it in adult patients with advanced solid tumors, including Japanese patients.

Who makes Gimatecan?

Gimatecan is being developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The company has sponsored Phase 1 clinical trials of this investigational oncology drug in patients with solid tumors and advanced solid tumors.

What phase is Gimatecan in?

Gimatecan is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. All completed trials for Gimatecan were Phase 1 dose-escalation studies, and no active trials are currently listed.

What clinical trials is Gimatecan in?

Gimatecan has been studied in three completed Phase 1 trials: NCT00410358, a dose escalation in Japanese patients with advanced solid tumors; NCT00420485, a dose-escalation study in adult patients with solid tumors; and NCT00441610, an extension trial in Japanese patients. These trials enrolled a total of 120 patients.

Is Gimatecan the same as LBQ707?

Yes, Gimatecan is also known as LBQ707. One clinical trial, NCT00487058, is titled 'A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors,' confirming that LBQ707 and Gimatecan refer to the same drug.