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TOMOX

Phase 2

Metastatic Colorectal Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jul 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

TOMOX · 1 trial · 1 indication

Phase 2 1
NCT02821559Biweekly Versus Triweekly Raltitrexed With Oxaliplatin (With or Without Bevacizumab) in First-line Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED37 Analytics
PHASE2COMPLETED
Biweekly Versus Triweekly Raltitrexed With Oxaliplatin (With or Without Bevacizumab) in First-line Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Evolution of Raltitrexed plasma levels
at 5 minutes, at 40 minutes, at 2 hours, at 7,5 hours, at 24 hours and at 14 days after each raltitrexed administration

pharmacokinetic study

Secondary Endpoints

treatment-related adverse events as assessed by CTCAE v4.0
3 months
objective response rate evaluated by RECIST 1.1 criteria
3 months
progression-free survival (PFS)
through study completion, an average of 2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
triweekly then biweeklyEXPERIMENTALThe arm A consisted of 2 cycles of triweekly TOMOX (standard dose 3mg/m2 of Raltitrexed in 15-minutes infusion, and 130mg/m2 of oxaliplatin in 2h infusion, every 3 weeks), followed by 2 cycles of biweekly TOMOX (2mg/m2 of Raltitrexed in 15-minutes infusion, and 85mg/m2 of oxaliplatin in 2h infusion, every 2 weeks).
biweekly then triweeklyEXPERIMENTALThe arm B consisted of the reserve sequence starting with 2 cycles of biweekly TOMOX followed by 2 cycles of triweekly TOMOX regimen.

Interventions

NameTypeDescription
TOMOXDRUG -
BevacizumabDRUGBevacizumab was allowed and used at 7,5 mg/kg or 5 mg/kg every 2 weeks.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * performance status (ECOG-PS) of 0 or 1 * patient with histologically proven colorectal cancer with distant metastases * measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * life expectancy \> 12 months * signed written informed consent Exc...

Countries:France
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Metastatic Colorectal Cancer")

Recent Changes (Last 90 Days)

MEDIUMAug 23, 2026NCT02821559TRIAL_REMOVED: changed
MEDIUMAug 23, 2026NCT02821559TRIAL_REMOVED: changed
MEDIUMAug 23, 2026NCT02821559TRIAL_REMOVED: changed

Frequently asked questions about TOMOX

What is TOMOX used for?

TOMOX is an investigational small molecule being studied for the treatment of metastatic colorectal cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes TOMOX?

TOMOX is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.

What phase is TOMOX in?

TOMOX is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. One Phase 2 clinical trial has been completed.

What clinical trials is TOMOX in?

TOMOX has been studied in one completed Phase 2 clinical trial, identified as NCT02821559. This trial evaluated biweekly versus triweekly raltitrexed with oxaliplatin, with or without bevacizumab, in first-line metastatic colorectal cancer.

Is TOMOX FDA approved?

TOMOX is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for metastatic colorectal cancer, and its safety and efficacy have not been established.