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RO4929097

Phase 2

Non-Squamous Non-Small Cell Lung Cancer | 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 Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

RO4929097 · 1 trial · 1 indication

Phase 2 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 Cancer
NCT010709277
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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)

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 -

Interventions

NameTypeDescription
RO4929097DRUG80mg po daily, 3 days on 4 days off schedule
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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:Netherlands
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Frequently asked questions about RO4929097

What is RO4929097 used for?

RO4929097 is an investigational small molecule being studied for the treatment of non-squamous non-small cell lung cancer. It is intended for patients with recurrent or refractory disease. The drug is in Phase 2 clinical development and is not yet approved for any use.

Who makes RO4929097?

RO4929097 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology drug for non-squamous non-small cell lung cancer.

What phase is RO4929097 in?

RO4929097 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of non-squamous non-small cell lung cancer, specifically in patients with recurrent or refractory disease.

What clinical trials is RO4929097 in?

RO4929097 has one completed Phase 2 clinical trial with the identifier NCT01070927. The study, titled "An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer," enrolled 7 participants in the Netherlands. The trial was controlled but not randomized or double-blinded.

Is RO4929097 the same as any other drug?

RO4929097 is the only name provided for this investigational drug. No alternative names have been reported. It is being developed by Roche Holding AG for the treatment of non-squamous non-small cell lung cancer.