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RO5429083

Phase 1

Myelogenous Leukemia, Acute | Small molecule | Oncology |Roche Holding AG|Trials Updated: Nov 2, 2016

RO5429083 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2011

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment109

FDA Designations

No designations recorded

RO5429083 clinical trials

RO5429083 · 2 trials · 2 indications

Phase 1 2
NCT01641250A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous LeukemiaMyelogenous Leukemia, Acute
COMPLETED44 Analytics
NCT01358903A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid TumorsNeoplasms
COMPLETED65 Analytics
PHASE1COMPLETED
A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
Myelogenous Leukemia, AcuteUnlock trial analytics
PHASE1COMPLETED
A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
approximately 24 months
Arm A: Safety (Incidence of adverse events related to study drug)
Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Maximum tolerated dose of RO5429083
Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Tumor Growth Control Rate
Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)
Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Pharmacokinetics (serum levels of RO5429083)
Until disease progression or unacceptable toxicity (approximately 2 years)

Secondary Endpoints

Clinical response according to hematologic malignancy assessments
approximately 24 months
Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)
Pre-dose and up to 96 hrs post-dose
Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)
Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: RO5429083EXPERIMENTAL -
Part B: RO5429083 + cytarabineEXPERIMENTAL -
AEXPERIMENTAL -
BEXPERIMENTAL -

Interventions

NameTypeDescription
RO5429083DRUGMultiple escalating doses
cytarabineDRUG1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * All non-hematological...

Countries:FranceGermanyItalyUnited StatesNetherlands
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Frequently asked questions about RO5429083

What is RO5429083 used for?

RO5429083 is an investigational small molecule being studied for the treatment of acute myelogenous leukemia and other neoplasms, including metastatic and locally advanced malignant solid tumors. It is in Phase 1 clinical development by Roche Holding AG.

What does RO5429083 target?

RO5429083 is being studied in patients with CD44-expressing malignant solid tumors. It is a small molecule developed for oncology indications, with clinical trials focusing on CD44-expressing tumors and acute myelogenous leukemia.

Who makes RO5429083?

RO5429083 is being developed by Roche Holding AG, a biopharmaceutical company. The drug is in Phase 1 clinical trials for oncology indications, including acute myelogenous leukemia and other neoplasms.

What phase is RO5429083 in?

RO5429083 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed Phase 1 trials in patients with acute myelogenous leukemia and with CD44-expressing malignant solid tumors.

What clinical trials is RO5429083 in?

RO5429083 has been studied in two completed Phase 1 trials. NCT01358903 evaluated the drug in patients with metastatic or locally advanced CD44-expressing malignant solid tumors. NCT01641250 studied it alone or with cytarabine in patients with acute myelogenous leukemia.

Is RO5429083 the same as any other drug?

RO5429083 is the sole name used for this investigational drug in clinical trials. No alternative names have been reported for this compound in the available clinical trial information.