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panitumumab, mytomicin C, 5-FU, radiation

Phase 2

Anal Squamous Cell Carcinoma | Small molecule | Oncology |Amgen Inc.|Last Updated: May 16, 2018

Target and mechanism

Molecular targetEGFR
Target classInhibitor
ModalitySmall molecule

Also known as Panitumumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

panitumumab, mytomicin C, 5-FU, radiation · 1 trial · 1 indication

Phase 2 1
NCT01285778Vectibix for the Treatment of Anal CancerAnal Squamous Cell Carcinoma
COMPLETED58 Analytics
PHASE2COMPLETED
Vectibix for the Treatment of Anal Cancer
Anal Squamous Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Three-year disease-free survival rate
3 years

To estimate the three-year disease-free survival rate in patients treated with 5-FU, mytomicin C and Panitumumab concurrently with radiation therapy as treatment for anal squamous cell carcinoma

Secondary Endpoints

Disease free survival rate
3 years
Three-year free local-regional failure rate
3 years
Overall survival
3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panitumumab, mytomicin C, 5-FU, radiationEXPERIMENTAL -

Interventions

NameTypeDescription
panitumumab, mytomicin C, 5-FU, radiationDRUGRadiation therapy will be administered concurrent with chemotherapy and Panitumumab treatment. It will start the day 1 of the systemic treatment. That is, the first day of radiation therapy will be the day of the administration of the first dose of Panitumumab and Mitomycin C, as well as the first day of the first 96-hours course of 5-FU continuous infusion. On day 1, drugs and radiation will be administered in the following order: * First, Panitumumab. Panitumumab will be administered by IV infusion on day 1, and every 2 weeks during 8 weeks * Then Mitomycin C, 10mg/m2 on days 1 and 29 * Then start the 5-FU continuous infusion, 1000mg/m2 on days 1-4 and 29-32 * Finally, no less than 2 hours after the start of the 5-FU infusion, first dose of radiation therapy.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Man or woman ≥ 18 years * Competent to comprehend, sign, and date an IEC-approved informed consent form * Histologically or cytologically-confirmed anal canal SCC * T status 2-4 and any N status (pelvic or inguinal) radiologically defined by MRI * De novo diagnosis of anal can...

Countries:Spain
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Frequently asked questions about panitumumab, mytomicin C, 5-FU, radiation

What is Panitumumab used for?

Panitumumab is an investigational drug being studied for use in colorectal cancer, tumors, cancer of the esophagus, mucinous adenocarcinoma of the colon, advanced renal cell carcinoma, and metastatic colorectal cancer. It is currently in Phase 2 clinical development for these oncology indications.

What does Panitumumab target?

Panitumumab is a monoclonal antibody, indicated by its -mab suffix, that targets the epidermal growth factor receptor (EGFR). It is being studied in various solid tumors, including colorectal cancer and non-small-cell lung cancer, where EGFR signaling is often dysregulated.

Who makes Panitumumab?

Panitumumab is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in multiple oncology indications.

What phase is Panitumumab in?

Panitumumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied in several cancer types, including colorectal cancer and head and neck cancer, but remains in clinical trials.

What clinical trials is Panitumumab in?

Panitumumab has been studied in several clinical trials, including NCT00658658 in children with solid tumors, NCT00756444 in head and neck cancer, NCT01042288 in non-small-cell lung cancer, and NCT01285778 in anal cancer. These trials are completed, with a total enrollment of 4111 patients across all studies.

Is Panitumumab the same as Vectibix?

Yes, Panitumumab is also known as Vectibix. In clinical trial NCT01285778, the drug is referred to as Vectibix for the treatment of anal squamous cell carcinoma. This alternative name is used in some research contexts.