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Solid TumorsPhase 1NCT01770353

MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

A Phase 1 study testing Ferumoxytol and MM-398 in people with Solid Tumors and ER/PR Positive Breast Cancer, run by Ipsen at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ferumoxytol and MM-398
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesUnited States
Study dates
Nov 2012to 2 Oct 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects:
  • Pathologically confirmed diagnosis of solid tumors
  • Metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
  • Adequate bone marrow, hepatic and renal function
  • Normal Electrocardiogram (ECG)
Show all 18Show fewer
  • 18 years of age or above
  • Able to understand and sign informed consent
  • Pilot study only:
  • CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, Gastroesophageal Junction (GEJ) adenocarcinoma, Head and Neck Cancer
  • Expansion Phase Additional Criteria:
  • Locally advanced or metastatic breast cancer
  • Received at least one cytotoxic therapy in the locally advanced and metastatic setting
  • Received ≤ 5 prior lines of chemotherapy in the metastatic setting
  • Candidate for chemotherapy
  • Expansion Phase Cohort 3 additional inclusion criteria:
  • Breast cancer with active brain metastasis
  • Neurologically stable

Who cannot join

  • Active Central nervous system (CNS) metastasis (applies to pilot phase and expansion phase cohort 1 and 2 only)
  • Clinically significant GI disorders
  • Prior irinotecan or bevacizumab therapy within last 6 months and for Expansion Phase patients, have received any prior treatment with Topol inhibitor
  • Known hypersensitivity to MM-398 or ferumoxytol
  • Inability to undergo MRI
  • Active infection
Show all 10Show fewer
  • Pregnant or breast feeding
  • Prior chemotherapy administered within 3 weeks, or within a time interval less than at least 5 half-lives of the agent, whichever is longer, prior to the first scheduled day of dosing in this study
  • Received radiation therapy in the last 14 days
  • Treated with parenteral iron in the previous 4 weeks

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Michighan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • UNC- Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Mayo Clinic

    Scottsdale, Arizona, 85159-5499

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Washington University

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33607

Other trials in United States

About this study

Official title: A Phase I Study in Patients Treated With MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.

Read the detailed description

This study is conducted over two phases.

Pilot Phase: This study will enroll approximately 12 patients, up to 20 in total in the Pilot Phase and 30 patients in the Expansion Phase. The first three patients that are enrolled in the Pilot Phase can have any solid tumor type; however subsequent patients must have Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Triple negative breast cancer (TNBC), Estrogen Receptor/Progesterone Receptor (ER/PR) positive breast cancer, pancreatic cancer, ovarian cancer, gastric cancer, gastro-oesophageal junction adenocarcinoma or head and neck cancer. No more than three patients with ER/PR positive breast cancer can be enrolled in the Pilot Phase and similar restrictions may be placed on other tumor types to ensure a heterogeneous population.

Expansion Phase: The expansion will enroll patients with advanced metastatic breast cancer into three cohorts of 10 patients each depending on sub-type of breast cancer:

Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis

Being tested
Ferumoxytol, MM-398
Keywords
solid tumors, Triple Negative Breast Cancer, Colorectal Cancer, MM-398, nanoliposomal irinotecan, Ferumoxytol, ER/PR positive Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, Gastro-Esophageal Junction Adenocarcinoma, Head and Neck Cancer, TNBC
Medical subject headings
Triple Negative Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FerumoxytolDrug

    Ferumoxytol 5 mg/kg IV as a single bolus injection, given once.

  • MM-398Drug

    MM-398 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity

Study groups in NCT01770353
Study groupRoleWhat they receive
Pilot Phase: Ferumoxytol followed by MM-398ExperimentalFerumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 IV over 90 min on Days 1 and 15 of every 4 week cycle
Receives: Drug: Ferumoxytol; Drug: MM-398
Expansion Phase: Ferumoxytol followed by MM-398ExperimentalFerumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 IV over 90 min dose 1 on Days 1 and 15 of every 4 week cycle Cohort 1: ER and/or PR-positive BC Cohort 2: TNBC Cohort 3: BC with active brain metastasis
Receives: Drug: Ferumoxytol; Drug: MM-398

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4

    Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal change on either the T2 or T1 sequences, based on FMX-MRI. The second core biopsy was taken from the region that showed the least signal change based on FMX-MRI, avoiding areas of necrosis.

    Measured: At Cycle 1 Day 4 in the Pilot phase.

  2. Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation

    Feasibility of FMX quantitation in tumour lesion was assessed through the acquisition of baseline (pre-FMX dose) and follow-up (post FMX dose) scans of sufficient quality to enable quantitative analysis to be performed. Quality was assessed by summarising scans as adequate for tumour evaluation or suboptimal but for which evaluation was completed for evaluation. Two FMX-MRI scans were taken on Day 1 (pre-FMX dosing) and on Day 2 (16-24 hours post dose) of the FMX phase. One MRI scan was also taken at 1-4 hours post FMX dose (Day 1 of FMX phase) and at 2 weeks post FMX dose (Day 15 of the MM-398 phase). It was possible for a subject to have 2 FMX-MRI scans for the same visit and timepoint corresponding to a scan target location. The number of MRI scan results that were assessed to be adequate or suboptimal at each timepoint are presented.

    Measured: Expansion phase Cycle 1: Pre FMX dose, 1-4 hours post FMX dose, 16-24 hours post FMX dose, 2 weeks Post FMX dose.

  3. Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose

    FMX tumour uptake was classified as 'low tumour uptake' or 'high tumour uptake', and was determined for 16 to 24-hours post-FMX dosing. The FMX uptake in a subject's lesions was classified using the median of the baseline-corrected FMX values at that timepoint across all subjects. The best radiological overall tumour response to MM-398 from the beginning to the end of the study was assessed using both the Investigator and imaging results per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Non-central nervous system [CNS] assessments; Cohorts 1, 2 and 3). Tumour response was classified as a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). BOR is presented by tumour uptake classification at 16-24 hours post-FMX dose by cohort for the non-CNS RECIST assessment.

    Measured: Expansion phase: C1D2 FMX phase, and every 8 weeks for RECIST assessments from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

Secondary outcomes (21)

  1. Pilot Phase + Expansion Phase: Median Progression-free Survival (PFS) (Non-CNS Assessment)

    PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by RECIST per Investigator assessment or death due to any cause, whichever occurred first.

    The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on non-CNS assessment is presented.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  2. Expansion Phase: Median PFS for Cohort 3 (CNS Assessment)

    PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by modified RECIST (mRECIST) criteria (CNS disease; Cohort 3) per Investigator assessment or death due to any cause, whichever occurred first.

    The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on CNS mRECIST assessment is provided for Cohort 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  3. Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment)

    BOR was defined as the best response by RECIST version 1.1 (Non-CNS assessments) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery.

    Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  4. Expansion Phase: BOR for Cohort 3 (CNS Assessment)

    BOR was defined as the best response by mRECIST criteria (CNS disease; Cohort 3) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery.

    Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for CNS assessments for Cohort 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  5. Pilot Phase + Expansion Phase: Objective Response Rate (ORR) (Non-CNS Assessment)

    The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  6. Expansion Phase: ORR for Cohort 3 (CNS Assessment)

    The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for CNS assessments for Cohort 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  7. Pilot Phase + Expansion Phase: Median Duration of Objective Response (DOR) (Non-CNS Assessment)

    DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using RECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1-3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  8. Expansion Phase: Median DOR for Cohort 3 (CNS Assessment)

    DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using mRECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for CNS assessments for Cohort 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  9. Pilot Phase + Expansion Phase: Clinical Benefit Response (CBR) (Non-CNS Assessment)

    CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for non-CNS assessments.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  10. Expansion Phase: CBR for Cohort 3 (CNS Assessment)

    CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for CNS assessment for Cohort 3.

    Measured: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.

  11. Pilot Phase + Expansion Phase: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) Related to MM-398

    The number of subjects who experienced a TEAE reported to be related to MM-398 by the Investigator are presented for the Pilot and Expansion phases. An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing.

    Measured: From MM-398 treatment start up to 30 days after last dose.

  12. Pilot Phase: Time to Reach Maximum Plasma Concentration of Irinotecan and SN-38 (Tmax)

    In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 salt-base equivalent [SBE]). The pharmacokinetic (PK) analysis was based on non-compartmental analysis. Any plasma concentrations below the lower limit of quantification (LLOQ) were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 micrograms per millilitre (mcg/mL), and for SN-38 the LLOQ for the Pilot phase was 0.441 nanograms per millilitre (ng/mL). The median tmax is presented for the Pilot phase.

    Measured: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

  13. Expansion Phase: Irinotecan and SN-38 Tmax

    For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL and for SN-38 the LLOQ for the Expansion phase was 0.600 ng/mL. The median tmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

    Measured: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

  14. Pilot Phase: Maximum Observed Plasma Concentration of Irinotecan (Cmax)

    In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Pilot phase.

    Measured: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

  15. Pilot Phase: SN-38 Cmax

    In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean Cmax is presented for the Pilot phase.

    Measured: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

  16. Expansion Phase: Irinotecan Cmax

    For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

    Measured: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

  17. Expansion Phase: SN-38 Cmax

    For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean Cmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

    Measured: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

  18. Pilot Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) for Irinotecan

    In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Pilot phase.

    Measured: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

  19. Pilot Phase: SN-38 AUC(0-tlast)

    In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean AUC(0-tlast) is presented for the Pilot phase.

    Measured: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.

  20. Expansion Phase: Irinotecan AUC(0-tlast)

    For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

    Measured: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

  21. Expansion Phase: SN-38 AUC(0-tlast)

    For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean AUC(0-tlast) is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.

    Measured: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2013 (estimated)
  2. Study startNov 2012
  3. Primary completion2 Oct 2018
  4. Study completion2 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01770353
Sponsor's protocol ID
MM-398-01-01-02
Status last verified
Nov 2019
First submitted
19 Dec 2012
Last updated
27 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • Ravi H, Arias-Lorza AM, Costello JR, Han HS, Jeong DK, Klinz SG, Sachdev JC, Korn RL, Raghunand N. Pretherapy Ferumoxytol-enhanced MRI to Predict Response to Liposomal Irinotecan in Metastatic Breast Cancer. Radiol Imaging Cancer. 2023 Mar;5(2):e220022. doi: 10.1148/rycan.220022.

    PubMed 36734848

  • Sachdev JC, Munster P, Northfelt DW, Han HS, Ma C, Maxwell F, Wang T, Belanger B, Zhang B, Moore Y, Thiagalingam A, Anders C. Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase. Breast Cancer Res Treat. 2021 Feb;185(3):759-771. doi: 10.1007/s10549-020-05995-7. Epub 2020 Nov 17.

    PubMed 33201358

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ferumoxytol and MM-398 in people with Solid Tumors and ER/PR Positive Breast Cancer, run by Ipsen at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4 (time frame: At Cycle 1 Day 4 in the Pilot phase.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01770353, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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