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dulanermin

Phase 1

Colorectal 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

RandomizedCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

dulanermin · 2 trials · 2 indications

Phase 1 2
NCT00873756A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED23 Analytics
NCT00671372A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal CancerColorectal Cancer
COMPLETED42 Analytics
PHASE1COMPLETED
A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics
PHASE1COMPLETED
A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and nature of dose-limiting toxicities
Until study discontinuation or the end of Cycle 26
The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux
Length of study
The safety and tolerability of dulanermin administered in combination with FOLFIRI (with or without Bevacizumab)
Length of study

Secondary Endpoints

Incidence, nature, and severity of adverse events
Until study discontinuation or the end of Cycle 26
Change in vital signs
Until study discontinuation or the end of Cycle 26
Change in clinical laboratory results
Until study discontinuation or the end of Cycle 26
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
Cohorts 1-5EXPERIMENTAL -
Cohorts 6, 6A, 7, 7AEXPERIMENTAL -

Interventions

NameTypeDescription
FOLFOX regimenDRUGIntravenous repeating dose
bevacizumabDRUGIntravenous repeating dose
dulanerminDRUGIntravenous repeating dose
FOLFIRI regimenDRUGIntravenous repeating dose
cetuximabDRUGIntravenous repeating dose
irinotecanDRUGIntravenous repeating dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease (i.e., by radiographic imaging or biopsy) and measurable tumor lesions * Life expectancy \> 3 months * For patients of reproductive potential (males and females), use of reliable mea...

Countries:United States
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Frequently asked questions about dulanermin

What is dulanermin used for?

Dulanermin is an investigational small molecule being studied for the treatment of colorectal cancer, including metastatic colorectal cancer. It is being developed by Roche Holding AG (ticker: RHHBY) and is currently in Phase 1 clinical development.

What does dulanermin target?

The molecular target of dulanermin has not been disclosed in available information. As a small molecule in oncology, it is being investigated for its potential role in treating colorectal cancer, but its specific mechanism of action is not publicly detailed.

Who makes dulanermin?

Dulanermin is being developed by Roche Holding AG, a multinational healthcare company traded under the ticker RHHBY. The drug is currently in Phase 1 clinical trials for colorectal cancer indications.

What phase is dulanermin in?

Dulanermin 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, both studying the drug in combination with other therapies for colorectal cancer.

What clinical trials is dulanermin in?

Dulanermin has been studied in two completed Phase 1 trials. NCT00671372 evaluated dulanermin with Camptosar/Erbitux chemotherapy or FOLFIRI (with or without bevacizumab) in previously treated metastatic colorectal cancer. NCT00873756 tested dulanermin with FOLFOX and bevacizumab in previously untreated colorectal cancer.

Is dulanermin the same as any other drug?

No alternative names for dulanermin have been reported. The drug is known only by its single name, dulanermin, in clinical trial records and development documentation.