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RG4733

Phase 2

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

RG4733 development status

Highest phase Phase 2 (NCT01070927)
Phase scored for RHHBYPhase 1
Registered trials 2 across 1 sponsor since Sep 2007

RG4733 target and mechanism

ModalitySmall molecule

Also known as RO4929097

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment117

FDA Designations

No designations recorded

RG4733 clinical trials

RG4733 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT01070927An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung CancerNon-Squamous Non-Small Cell Lung Cancer
COMPLETED7 Analytics
PHASE2COMPLETED
An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
Non-Squamous Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Tumour blood flow and tumour metabolic response rate
PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)
AEs, laboratory parameters.
Throughout study

Secondary Endpoints

Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)
pharmacokinetics: cycle 1 on days 1, 2, 4, 10, 11, 16; cycle 2 on days 1, 2, 16\npharmacodynamics: cycle 1 on days 1, 2, 4, 11, 16; cycle 2 on days 1, 16
Tumour response according to RECIST criteria
assessments once every 2nd cycle on day 16
Safety and tolerability: AEs, laboratory parameters
throughout study, laboratory assessments on days 1, 8 and 15 of each cycle
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
cohort 1EXPERIMENTAL -
cohort 2EXPERIMENTAL -
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
RO4929097DRUG80mg po daily, 3 days on 4 days off schedule
RG4733DRUGAdministered orally daily at ascending doses to successive cohorts of patients
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * adult patients, \>/= 18 years of age * stage IIIB/IV recurrent or refractory non-small cell lung cancer * at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy) * ECOG performance...

Countries:NetherlandsUnited States
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Frequently asked questions about RG4733

What is RG4733 used for?

RG4733 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being studied in the oncology therapeutic area for patients with advanced solid tumors.

Who makes RG4733?

RG4733 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market.

What phase is RG4733 in?

RG4733 is in Phase 1 clinical development. It has completed a Phase 1 trial, and it remains an investigational drug that is not yet approved for any use.

What clinical trials is RG4733 in?

RG4733 has one completed clinical trial, identified as NCT00532090. This was a multiple ascending dose study in patients with advanced solid tumors, conducted in the United States with 110 participants aged 18 years and older.

Is RG4733 the same as R4733?

Yes, RG4733 is also referred to as R4733. The clinical trial NCT00532090, titled 'A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors,' uses the R4733 name for the same drug.