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Advanced Solid TumorsPhase 1NCT02040558

Trial to Study the Safety of Intravenous MNK-010 in Advanced Solid Tumors

A Phase 1 study testing MNK-010 in people with Advanced Solid Tumors, run by Mallinckrodt at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with advanced solid malignancies who have failed conventional therapy. The safety, tolerability, pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of MNK-010 will be evaluated in subjects with advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
MNK-010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Jul 2013to Jul 2016
Phase
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

  • Diagnosis of an advanced solid tumor malignancy.
  • Histological or cytological evidence of malignancy.
  • Advanced malignancy, metastatic or unresectable, that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo, standard therapy.
  • Disease that is currently not amenable to curative surgical intervention.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and a life expectancy > 12 weeks.
  • Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
Show all 11Show fewer
  • 18 years or older, of either sex, and of any race
  • Female subjects of childbearing potential must have negative pregnancy test within 7 days prior to first dose of study drug; practicing an acceptable form of birth control for greater than 2 months prior to screening and commits to use for the duration of the study and for 3 months following the last dose of study treatment.
  • Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 3 months after the last dose of study treatment in such a manner that the risk of pregnancy for a partner is minimized.
  • Prior to study treatment administration, at least 21 days must have elapsed since the subject's prior investigational or non-investigational systemic therapy, or any major surgery, and at least 21 days since prior radiotherapy.
  • Subjects with a history of prior radiotherapy are eligible if they meet the following parameters: Prior to study treatment administration, must be ≥ 21 days post-therapy and have recovered from all toxicities; must have evidence of measurable disease outside the radiation fields or radiologically confirmed progression of disease; must not have had > 25% of their functional bone marrow irradiated. Must have radiologically measureable disease, a life expectancy > 12 weeks, and adequate organ function.

Who cannot join

  • Subject has received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, whether conventional or investigational, major surgery within 21 days, or radiotherapy within 21 days of treatment in this study, or at any time during the study.
  • Subject has an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
  • Subject has symptomatic or untreated central nervous system (CNS) metastases; any type of active seizure disorder; febrile neutropenia; ≥ Grade 2 peripheral neuropathy; peritoneal or pleural effusions requiring a tap more frequently than every 14 days; QT interval corrected (QTc) prolongation or a prior history of serious arrhythmias or significant abnormalities on screening ECG; previously experienced a severe reaction to a liposomal product or a taxane; received IV treatment for bacterial/fungal infection within 7 days of screening.
  • Subject has known significant cardiovascular disease or cerebrovascular accident within 3 months of enrollment, or within the timeframe as stipulated in the additional criteria outlined in the protocol.
  • Subject requires the use of the following concomitant treatments/procedures at any time, per protocol.
  • Subject requires either moderate or strong (if weak, 2 or more) inhibitors or inducers of Cytochrome P450 3A (CYP3A) mediated metabolism.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, Phase 1 First in Human Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous MNK-010 in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with advanced solid malignancies who have failed conventional therapy. The safety, tolerability, pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of MNK-010 will be evaluated in subjects with advanced solid tumors.

Being tested
MNK-010

What participants receive

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

  • MNK-010Drug

Study groups in NCT02040558
Study groupRoleWhat they receive
MNK-010ExperimentalSubjects will receive 1 dose of MNK-010 followed by a 7-day post dose assessment period per treatment cycle. Dose levels will be based upon the amount of active delivered per square meter of body surface area (mg/m2). Cycles will repeat every 3 weeks (21 days) based on toxicity and response, as determined by a Safety Review Committee (SRC). Subjects will continue treatment with MNK-010 until unacceptable toxicity, documented progression of disease, another criterion for discontinuation is met, or until 4 treatment cycles have been completed.
Receives: Drug: MNK-010

What is being measured

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

  1. Maximum tolerated dose (MTD)

    MTD of MNK-010

    Measured: 27 months

  2. Treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of at least Grade 3 severity, and discontinuations due to AEs. AEs will be evaluated and categorized in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events

    Measured: 27 months

  3. Clinical labs

    Changes from baseline in clinical laboratory assessments, vital signs, arterial oxygen saturation (SaO2) by pulse oximetry, physical examination, and 12-lead electrocardiograms (ECGs)

    Measured: 27 months

Secondary outcomes (2)

  1. Plasma PK

    Standard plasma PK parameters will be measured following single and multiple doses.

    Measured: 27 months

  2. Overall response

    Best confirmed overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 27 months

Timeline

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

  1. First posted20 Jan 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2016
  4. Study completionJul 2016

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02040558
Sponsor's protocol ID
COV10100386
Status last verified
Apr 2017
First submitted
13 Jan 2014
Last updated
5 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Paira S, Borden KLB. Multipurpose RNA maturation factors dysregulate multiple mRNA processing steps simultaneously and provide new therapeutic opportunities. RNA Biol. 2025 Dec;22(1):1-14. doi: 10.1080/15476286.2025.2503040. Epub 2025 Jun 9.

    PubMed 40485569

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MNK-010 in people with Advanced Solid Tumors, run by Mallinckrodt at 1 site 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 11 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early. Results are not available in the source record.

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?

Maximum tolerated dose (MTD) (time frame: 27 months). 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 NCT02040558, which also lists 1 linked publication.

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 5 Apr 2017.

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