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Maintenance Chemotherapy

Phase 2

Metastatic Colorectal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Jun 15, 2023

Target and mechanism

ModalitySmall molecule

Also known as IV Chemotherapy (Regimen 1), Chemotherapy

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment387

FDA Designations

No designations recorded

Clinical trial landscape

Maintenance Chemotherapy · 1 trial · 1 indication

Phase 2 1
NCT01991873Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED387 Analytics
PHASE2COMPLETED
Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival
Until end of follow-up (24 months after randomization)

Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.

Secondary Endpoints

failure of treatment strategy
Until end of follow up (24 months after randomization)
Progression-free survival of re-induction
From start of re-induction therapy until progress or end of follow-up (24 months after randomization)
Objective response after 12 weeks of induction chemotherapy
12 weeks after start of induction chemotherapy
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Maintenance Chemotherapy + PanitumumabEXPERIMENTALMaintenance therapy: Panitumumab 6 mg/kg prior to administration of chemotherapy Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15 Re-induction upon progression: Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy. mFOLFOX6: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15
Maintenance Chemotherapy w/o PanitumumabEXPERIMENTALMaintenance therapy: Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15 Re-induction upon progression: Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy. mFOLFOX6 chemotherapy: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Interventions

NameTypeDescription
Maintenance ChemotherapyDRUG -
Panitumumab (Within maintenance phase)DRUG -
mFOLFOX6 (Within re-induction phase)DRUG -
Panitumumab (Within re-induction phase)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Signed written informed consent * Male or female ≥ 18 years of age * Histologically proven metastatic colorectal cancer * Molecular testing showing RAS wild-type in colorectal carcinoma cells * Life expectancy \> 12 weeks * At least one measurable lesion according to RECIST 1....

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

Frequently asked questions about Maintenance Chemotherapy

What is Maintenance Chemotherapy used for?

Maintenance Chemotherapy is used for cancer, including metastatic colorectal cancer. It is an investigational small molecule therapy being studied as a maintenance treatment after initial induction therapy for patients with metastatic colorectal cancer. The drug is in Phase 2 clinical development.

Who makes Maintenance Chemotherapy?

Maintenance Chemotherapy is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic colorectal cancer.

What phase is Maintenance Chemotherapy in?

Maintenance Chemotherapy is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the maintenance treatment of metastatic colorectal cancer following induction therapy.

What clinical trials is Maintenance Chemotherapy in?

Maintenance Chemotherapy has been studied in clinical trial NCT01991873, a Phase 2 trial titled 'Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer.' This trial enrolled 387 patients in Germany and has been completed.

Is Maintenance Chemotherapy the same as IV Chemotherapy?

Yes, Maintenance Chemotherapy is also known as IV Chemotherapy (Regimen 1) and Chemotherapy. These alternative names refer to the same drug being developed by Amgen Inc. for the treatment of metastatic colorectal cancer.