Recent Updates
Recently added Catalysts

rHuEPO

Phase 4

Cancer | Small molecule | Oncology |Amgen Inc.|Trials Updated: Feb 28, 2008

rHuEPO development status

Highest phase Phase 4 run by AstraZeneca (NCT04655027)
Phase scored for AMGNPhase 3
Registered trials 4 across 2 sponsors since May 2002

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment718

FDA Designations

No designations recorded

rHuEPO clinical trials

rHuEPO · 1 trial · 2 indications

Phase 3 1
NCT00111137Treatment for Patients With Non-Myeloid Malignancies Receiving ChemotherapyCancer
COMPLETED718 Analytics
PHASE3COMPLETED
Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to hematopoietic response during the comparative treatment period
during the comparative treatment period

Secondary Endpoints

Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)
during the study
Incidence, if any, of neutralizing antibody formation to study drug
throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
baseline to first month of treatment
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
rHuEPOACTIVE_COMPARATOR -
Darbepoetin alfaEXPERIMENTAL -

Interventions

NameTypeDescription
rHuEPODRUGrHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
Darbepoetin alfaDRUG4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more * Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy * Karnofsky performance status of...

Unlock Eligibility Criteria

Competitive Landscape -Cancer 7 trials

Unlock Competitive Intelligence

Frequently asked questions about rHuEPO

What is rHuEPO used for in cancer?

rHuEPO is an investigational therapy studied for patients with cancer, specifically those with non-myeloid malignancies who are receiving chemotherapy. It has been evaluated in a Phase 3 clinical trial in this patient population. It is not described as an approved treatment in the available information.

Who is developing rHuEPO?

rHuEPO is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor associated with the clinical development program for this asset in oncology.

What phase is rHuEPO in?

rHuEPO is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently listed as active. The program has enrolled 718 patients in total across its clinical studies.

What clinical trials is rHuEPO in?

rHuEPO has been evaluated in the Phase 3 trial NCT00111137, titled Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy. That trial is completed and enrolled 718 patients. It was randomized and used an active control design, and participants were adults aged 18 years and older.

Is rHuEPO approved by the FDA?

rHuEPO is described as being in Phase 3 clinical development, which means it remains investigational. The available information does not indicate that it has received FDA approval for the cancer indication studied. Development status should be confirmed through regulatory filings and the sponsor.