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RO5503781

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

RO5503781 · 2 trials · 1 indication

Phase 1 2
NCT01901172A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid TumorsNeoplasms
COMPLETED61 Analytics
NCT01462175A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except LeukemiaNeoplasms
COMPLETED99 Analytics
PHASE1COMPLETED
A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors
NeoplasmsUnlock trial analytics
PHASE1COMPLETED
A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Area under the concentration-time curve (AUC)
22 days
Part 1: Maximum concentration (Cmax)
22 days
Part 1: Change in serum macrophage inhibitory cytokine-1 (MIC-1)
from baseline to Day 22
Part 2: Relative bioavailability: Area under the concentration-time curves (AUCs)
22 days
Part 3: Food effect: Area under the concentration-time curves (AUCs)
28 days
Maximum Tolerated Dose (MTD)
up to 28 days
Percentage of Participants With Dose Limiting Toxicities (DLTs)
up to 28 days
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
approximately 1.5 years

Secondary Endpoints

Safety: Incidence of adverse events in combination with posaconazole
28 days
Safety: Incidence of adverse events (new formulations)
28 days
Safety: Incidence of adverse events (optional treatment extension)
approximately 1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
ExtensionEXPERIMENTAL -
Part 1: Drug-drug interactionEXPERIMENTAL -
Part 2: Relative bioavailabilityEXPERIMENTAL -
Part 3: Food effectEXPERIMENTAL -
Schedule A: RO5503781 QWEXPERIMENTALParticipants will receive multiple ascending doses of RO5503781 orally once weekly (QW) x 3 followed by 13 days of rest in a 28 days cycle.
Schedule B: RO5503781 QDEXPERIMENTALParticipants will receive multiple ascending doses of RO5503781 orally QD x 5 followed by 13 days of rest in a 28 days cycle.

Interventions

NameTypeDescription
RO5503781DRUGSingle dose on Day 1 (high fat, low fat, or fasted), Day 10 (fasted, low fat, or high fat), and Day 19 (low fat, fasted, or high fat) in a crossover design
posaconazoleDRUGMultiple doses Days 8-14
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Eligibility Criteria

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

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient * M...

Countries:United StatesCanadaAustraliaFranceNetherlandsSouth Korea
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Frequently asked questions about RO5503781

What is RO5503781 used for?

RO5503781 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed by Roche Holding AG for use in oncology. The drug is currently in Phase 1 clinical development.

How does RO5503781 work?

RO5503781 is a small molecule being developed by Roche Holding AG for oncology indications. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential effects on neoplasms, though its precise mechanism of action is not publicly detailed.

Who makes RO5503781?

RO5503781 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the safety and efficacy of this investigational small molecule for the treatment of neoplasms. The company's stock is traded under the ticker RHHBY.

What phase is RO5503781 in?

RO5503781 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 160 participants enrolled. The drug is investigational and has not been approved by regulatory authorities. It is being studied for the treatment of neoplasms in oncology.

What clinical trials is RO5503781 in?

RO5503781 has been studied in two completed Phase 1 clinical trials. The first, NCT01462175, was a first-in-human study in participants with advanced malignancies except leukemia, enrolling 99 participants across Australia, Canada, France, Netherlands, and South Korea. The second, NCT01901172, studied drug-drug interactions and new formulations in 61 patients with solid tumors in the United States and Canada.

Is RO5503781 the same as any other drug?

RO5503781 is the primary name used for this investigational drug in clinical trial registrations. No alternative names have been associated with this compound in the available trial information. It is being developed by Roche Holding AG for the treatment of neoplasms.