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RO5429083

Phase 1

Myelogenous Leukemia, Acute | 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

CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

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, specifically in patients with CD44-expressing malignant solid tumors. It is being developed by Roche Holding AG (RHHBY) and is currently in Phase 1 clinical development.

What does RO5429083 target?

RO5429083 targets CD44, a cell surface glycoprotein involved in cell adhesion and signaling. It is being studied in patients with CD44-expressing malignant solid tumors, as well as in acute myelogenous leukemia. The drug is designed to interfere with CD44-mediated pathways in cancer cells.

Who makes RO5429083?

RO5429083 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications, including acute myelogenous leukemia and solid tumors.

What phase is RO5429083 in?

RO5429083 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in solid tumors and one in acute myelogenous leukemia, but the drug remains in early-stage clinical testing.

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, enrolling 65 participants in the United States, France, and the Netherlands. NCT01641250 studied the drug alone or with cytarabine in acute myelogenous leukemia, enrolling 44 participants in France, Germany, and Italy.

Is RO5429083 the same as other names?

RO5429083 is the primary name for this investigational drug. No alternative names have been reported in clinical trial records. It is identified solely by its compound number, RO5429083, in the studies conducted by Roche.