AzTrials
AzTrials

Brain MetastasesEarly Phase 1NCT02735798

64-Cu Labeled Brain PET/MRI for MM-302 in Advanced HER2+ Cancers With Brain Mets

A Early Phase 1 study testing MM-302 and Trastuzumab in people with Brain Metastases and Documented Her2 Overexpression, run by Pamela Munster.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a single arm pilot study of 64Cu-MM-302 and unlabeled MM-302 in combination with trastuzumab in 10 patients with advanced HER2+ cancer with new or progressive brain metastases. Patients will receive standard imaging at baseline, including FDG-PET/CT plus MR brain imaging. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MM-302 and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2016to Jun 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • Histologically confirmed advanced solid tumor malignancy with documented HER2 overexpression or gene amplification on prior archival tumor tissue by CLIA-certified laboratory
  • New or progressive brain metastases with at least one metastasis measuring ≥ 1 cm in longest diameter on MR imaging
  • Patients may have extra-cranial metastatic disease but this is not required for study entry
  • Neurologically stable as defined by ALL of the following:
  • Stable or decreasing dose of steroids and anti-convulsants for at least 14 days prior to study entry
  • No clinically significant mass effect, midline shift, or impending herniation on baseline brain imaging
Show all 17Show fewer
  • No significant focal neurologic signs and/or symptoms which would necessitate radiation therapy or surgical decompression in the judgment of the treating clinician
  • Prior radiation therapy for treatment of brain metastases completed at least 4 weeks prior to study entry
  • Prior radiation therapy for brain metastases allowed but must have been at least 4 weeks prior to study entry and follow up imaging is not consistent with pseudoprogression in the judgment of treating clinician
  • Patients must be ambulatory with ECOG performance status of 0 - 1.
  • Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/uL, hemoglobin ≥9.0 gm/dL, platelets ≥100,000 cells/uL, estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation), bilirubin <1.5x ULN (unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5x ULN (< 3x ULN if known liver metastases).
  • Ejection fraction as assessed by MUGA or echocardiogram > 50%
  • Prior cumulative doxorubicin exposure < 300 mg/m2 (or epirubicin equivalent)
  • Last dose of prior systemic anti-cancer therapy administered at least 5 half-lives or 4 weeks prior to study entry, whichever is shorter
  • No contra-indications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia)
  • Patients will sign a study-specific IRB-approved consent prior to study entry. Patients must be able and willing to consent and undergo study procedures.
  • Age ≥18 years old

Who cannot join

  • Prior treatment with MM-302
  • Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF)
  • Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
  • Patients with persistently uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical therapy
  • Patients with known unstable angina pectoris
  • Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
Show all 12Show fewer
  • Patients with a prolonged QTc interval (≥ 450 ms)
  • Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
  • Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.
  • Current dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other medical condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures
  • Presence of leptomeningeal disease in the absence of parenchymal brain metastases

About this study

Official title: A Pilot Study of 64-Cu Labeled Brain PET/MRI for MM-302, a Novel HER2 Targeting Agent, in Advanced HER2+ Cancer With Brain Metastases

This is a single arm pilot study of 64Cu-MM-302 and unlabeled MM-302 in combination with trastuzumab in 10 patients with advanced HER2+ cancer with new or progressive brain metastases. Patients will receive standard imaging at baseline, including FDG-PET/CT plus MR brain imaging. Patients will subsequently start protocol therapy with MM-302 and trastuzumab given on day 1 of an every 21-day dosing cycle, at the recommended phase 2 dose of 30 mg/m2. Patients will receive 64Cu-labeled MM-302 (3-5 mg/m2 doxorubicin) three hours after unlabeled dose of MM-302. Integrated MR/PET imaging of the brain and whole body will be performed at two time points following 64Cu-labeled MM-302 administration: (1) within 3 hours (+/- 1 hour) of labeled drug injection, and (2) 24 hours (+/- 6 hours) post-injection. Patients will continue to receive subsequent doses of unlabeled MM-302 plus trastuzumab every 3 weeks until clinical or radiographic disease progression (either in the brain or systemically) or unacceptable toxicity, whichever occurs soonest. MR brain imaging and FDG-PET/CT scans will be performed every 9 weeks to monitor for treatment response and disease progression.

Being tested
MM-302, Trastuzumab
Medical subject headings
Brain Neoplasms

What participants receive

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

  • MM-302Drug

    Also called MM-302 brain study

  • TrastuzumabDrug

    Also called Herceptin

Study groups in NCT02735798
Study groupRoleWhat they receive
Single Arm Study - Arm 1Experimental10 patients will receive standard imaging at baseline, incl. FDG-PET/CT plus MR brain imaging. Patients will subsequently start protocol therapy with MM-302 and trastuzumab given on day 1 of an every 21-day dosing cycle, at recommended phase 2 dose of 30 mg/m2. Patients will receive 64Cu-labeled MM-302 (3-5 mg/m2 doxorubicin) 3 hours after unlabeled dose of MM-302. Integrated MR/PET imaging of brain and whole body will be performed at 2 time points following 64Cu-labeled MM-302 administration: (1) within 3 hours (+/- 1 hour) of labeled drug injection, and (2) 24 hours (+/- 6 hours) post-injection. Patients will continue to receive doses of unlabeled MM-302 plus trastuzumab every 3 weeks until clinical or radiographic disease progression (in brain or systemically) or unacceptable toxicity, whichever occurs soonest. MRI and FDG-PET/CT scans will be performed every 9 weeks to monitor for treatment response and disease progression.
Receives: Drug: MM-302; Drug: Trastuzumab

What is being measured

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

  1. MM-302 drug penetration into the brain

    by Positron emission tomography-magnetic resonance (MR/PET) imaging

    Measured: 3 hours

Secondary outcomes (9)

  1. Adverse event

    In overall cohort NCI CTCAE v.4.0

    Measured: 1 year

  2. Overall response rate

    By Revised Assessment in Neuro-Oncology (RANO) criteria

    Measured: 1 year

  3. Overall response rate

    By Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria

    Measured: 1 year

  4. Progession-free survival

    In the central nervous system (CNS)

    Measured: 1 year

  5. Progession-free survival

    Systemically

    Measured: 1 year

  6. CNS response rate

    In overall cohort

    Measured: 1 year

  7. Systemic response rate

    In overall cohort

    Measured: 1 year

  8. Adverse Event

    Treatment with radioactive MM-302

    Measured: 1 year

  9. Adverse Event

    Treatment with MM-302 and trastuzumab

    Measured: 1 year

Timeline

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

  1. First posted13 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2018 (estimated)

Why it stopped: The study was not started due to the sponsor choosing to not fund the trial.

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02735798
Sponsor's protocol ID
15952
Status last verified
May 2017
First submitted
1 Apr 2016
Last updated
4 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MM-302 and Trastuzumab in people with Brain Metastases and Documented Her2 Overexpression, run by Pamela Munster.

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 17 inclusion and 12 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: withdrawn, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

MM-302 drug penetration into the brain (time frame: 3 hours). 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 NCT02735798.

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 4 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in