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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01770353

NCT01770353
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a solid tumor (a type of cancer that forms a solid mass), confirmed by laboratory testing
  • Your cancer has spread to other parts of the body (metastatic disease)
  • You are generally well enough to carry out daily activities with little or no limitation (your doctor can confirm this using a standard fitness scale)
  • Your blood, liver, and kidney test results are within acceptable ranges
  • Your heart tracing (ECG) is normal
  • You are 18 years of age or older
  • You are able to understand and agree to take part by signing a consent form
  • For the pilot part of the study only: your cancer is one of these types — colorectal, triple-negative breast cancer, ER/PR breast cancer, non-small cell lung cancer, pancreatic, ovarian, gastric, gastroesophageal junction, or head and neck cancer
  • For the expansion phase only: you have locally advanced or metastatic breast cancer, have had at least one chemotherapy treatment for your advanced cancer, have had no more than five chemotherapy regimens for metastatic disease, and are considered suitable for further chemotherapy
  • For one specific expansion group (Cohort 3) only: you have breast cancer that has spread to the brain and your neurological condition is stable

Who may not be able to join:

  • You have active cancer spread to the brain or spinal cord (this applies to the pilot phase and two of the expansion groups, but not Cohort 3)
  • You have significant stomach or bowel problems
  • You have received the drugs irinotecan or bevacizumab in the last 6 months, or — if in the expansion phase — you have previously had any treatment with a topoisomerase inhibitor (a specific type of cancer drug) (confirm with trial site)
  • You have a known allergy to MM-398 or ferumoxytol (the study drugs)
  • You are unable to have an MRI scan
  • You currently have an active infection
  • You are pregnant or breastfeeding
  • You have had chemotherapy within the last 3 weeks, or within a timeframe based on how long the drug stays in your body — whichever is longer (confirm with trial site)
  • You have had radiation therapy within the last 14 days
  • You have received iron given through a drip or injection in the last 4 weeks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Ipsen
Registry
clinicaltrials_gov
Start date
1 November 2012
Est. completion
2 October 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4; Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation; Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov