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RO5083945

Phase 2

Colorectal Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 17, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment169

FDA Designations

No designations recorded

Clinical trial landscape

RO5083945 · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT01326000A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal CancerColorectal Cancer
COMPLETED169 Analytics
NCT01185847A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung CancerNon-Squamous Non-Small Cell Lung Cancer
COMPLETED90 Analytics
PHASE2COMPLETED
A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer
Colorectal CancerUnlock trial analytics
PHASE2COMPLETED
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Non-Squamous Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
approximately 18 months
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI
23 months
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
6 months
immune cell infiltration head and neck squamous cell cancer (HNSCC)
through study completion or early study discontinuation
Pharmacokinetic parameters, and maximum tolerated dose (Part 1)
Throughout study
Tumor growth control rate (CR, PR, SD) (Part 2)
Event driven

Secondary Endpoints

Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
approximately 18 months
Duration of response: time from complete or partial response to disease progression or death
approximately 18 months
Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
approximately 18 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KRAS WT AEXPERIMENTAL -
KRAS WT BACTIVE_COMPARATOR -
KRAS mutant AEXPERIMENTAL -
KRAS mutant BACTIVE_COMPARATOR -
A non-squamousEXPERIMENTAL -
A squamousEXPERIMENTAL -
B non-squamousACTIVE_COMPARATOR -
B squamousACTIVE_COMPARATOR -
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
1EXPERIMENTAL -

Interventions

NameTypeDescription
FOLFIRIDRUGstandard iv chemotherapy
RO5083945DRUG1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
cetuximabDRUG400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
cisplatinDRUGstandard treatment, up to 6 cycles
gemcitabineDRUGstandard treatment, up to 6 cycles
pemetrexedDRUGstandard treatment, up to 6 cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Carcinoma of the colon and/or rectum * Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease * ECOG performance status 0-1 * Adequate hematological, rena...

Countries:United StatesAustraliaBelgiumFranceGermanyItalyPolandSpainUnited KingdomNetherlands
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Frequently asked questions about RO5083945

What is RO5083945 used for?

RO5083945 is an investigational oncology drug being studied for the treatment of neoplasms, non-squamous non-small cell lung cancer, head and neck cancer, and colorectal cancer. It is developed by Roche Holding AG (RHHBY) and is currently in Phase 2 clinical development.

How does RO5083945 work?

RO5083945 is a small molecule that targets the epidermal growth factor receptor (EGFR), as indicated by its clinical trials in patients with EGFR+ solid tumors. By targeting EGFR, it aims to interfere with cancer cell growth and survival pathways.

Who makes RO5083945?

RO5083945 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 various oncology indications.

What phase is RO5083945 in?

RO5083945 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RO5083945 in?

RO5083945 has been studied in several completed trials, including NCT00721266 (Phase 1, solid tumors), NCT01046266 (Phase 1, head and neck cancer), NCT01185847 (Phase 2, non-small cell lung cancer), and NCT01326000 (Phase 2, colorectal cancer). These trials enrolled a total of 169 patients.

Is RO5083945 the same as cetuximab?

No, RO5083945 is not the same as cetuximab. In a Phase 2 trial for metastatic colorectal cancer, RO5083945 was compared against FOLFIRI plus cetuximab or FOLFIRI alone, indicating they are distinct treatments being evaluated in the same setting.