Recruiting
Phase 2

Iron Replacement

Sponsor:

Fox Chase Cancer Center

Code:

NCT05800600

Conditions

Anemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Venofer

Study Details

Brief summary:

This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.

Conditions

Anemia

Study ID

NCT05800600

Start date

Mar 15, 2023

Status verified date

May, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients > 18 years
  • Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.
  • Anemia defined as Hgb <10.5 g/dL during chemotherapy.
  • Iron storage levels of ferritin <500 ng/mL and iron saturation <35%
  • Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion Criteria:

  • Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb < 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Prior parenteral iron infusion in the past 4 weeks
  • The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
  • Concurrent systemic infection at the time of enrollment.
  • Known hypersensitivity to Iron sucrose
  • Pregnant or breast feeding. Refer to section 4.4 for further detail.
  • Anemia from another established etiology (i.e MDS, Myeloma)

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Venofer treatment

Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion

Interventions

Venofer

Intravenous iron will be administered as five doses of 200 mg of iron sucrose (Venofer, American Regent, Shirley, NJ) in 100 ml normal saline over a duration of 15 minutes to 1 hour

Primary outcome measure

  • Mean change from baseline to highest Hgb value [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Ryan Romasko

2678388380ryan.romasko@fccc.edu

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Ryan Romasko

267-838-8380ryan.romasko@fccc.edu

Principal Investigator:

Iberia Sosa, MD

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2026-05-22.