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Genz-644282

Phase 1

Solid Tumors | Small molecule | Oncology |Sanofi|Last Updated: Mar 19, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment87

FDA Designations

No designations recorded

Clinical trial landscape

Genz-644282 · 1 trial · 1 indication

Phase 1 1
NCT00942799Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid TumorsSolid Tumors
COMPLETED87 Analytics
PHASE1COMPLETED
Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the Maximum Tolerated Doses for the 28-day and 21-day dosing schedules
24 Months

Secondary Endpoints

Determine the recommended Phase 2 doses for the 28-day and 21-day dosing schedules
36 Months
Establish the pharmacokinetic (PK) profile through calculation of area under the curve of blood and urine concentrations.
36 Months
Pharmacokinetics (PK) as measured by maximal observed concentration (Cmax)
36 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study Drug: Genz-644282 (28-day dosing schedule)EXPERIMENTALGenz-644282 (Each cohort will be based on dose-escalation)
Study Drug: Genz-644282 (21-day dosing schedule)EXPERIMENTALGenz-644282 (Each cohort will be based on dose-escalation)

Interventions

NameTypeDescription
Genz-644282 (28-day dosing schedule)DRUGGenz-644282 will be administered as a 60-minute IV infusion. The initial dose of Genz-644282 will be 0.5 mg/m2 and will be administered once weekly for 3 consecutive weeks on Day 1, Day 8, and Day 15 of the 28 day cycle. Each 28-day period will represent one treatment cycle. Study drug will continue to be given until disease progression or unacceptable toxicity is observed.
Genz-644282 (21-day dosing schedule)DRUGThe starting dose of Genz-644282 for the 21-day schedule will be prescriptive and will be based on review of available safety data from the 28-day dosing schedule by the Investigator and Sponsor. Patients will receive Genz-644282 once-weekly for 2 consecutive weeks on Day 1 and Day 8 of a 21 day cycle. Each 21-day period will represent 1 treatment cycle. Patients enrolled in subsequent cohorts will receive higher doses until the MTD is established.
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Eligibility Criteria

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

Inclusion Criteria: * Signed written informed consent * Patients enrolled in dose-escalation phase: Histologically or cytologically confirmed advanced malignant solid tumor for which no standard therapeutic option exists. * For the disease indications evaluated in the expansion phase, the following...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about Genz-644282

What is Genz-644282 used for?

Genz-644282 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development, with a completed dose escalation study assessing its safety and tolerability in patients with solid tumors.

Who makes Genz-644282?

Genz-644282 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical development for the treatment of solid tumors.

What phase is Genz-644282 in?

Genz-644282 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for the treatment of solid tumors. One Phase 1 trial has been completed.

What clinical trials is Genz-644282 in?

Genz-644282 has one completed clinical trial, identified as NCT00942799. This was a Phase 1 dose escalation study to assess the safety and tolerability of Genz-644282 in patients with solid tumors, conducted in the United States with 87 participants.

Is Genz-644282 the same as any other drug?

No alternative names for Genz-644282 have been reported. It is known by the name Genz-644282 and is being developed by Sanofi for the treatment of solid tumors.