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Follicular LymphomaPhase 2NCT01939899

Phase 2 Study of Oral IXAZOMIB in Adult Participants With Relapsed and/or Refractory Follicular Lymphoma

A Phase 2 study testing IXAZOMIB in people with Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 14 sites in 4 countries.

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

The primary purpose of this study is to evaluate the anti-tumor activity of oral Ixazomib as measured by overall response rate (ORR) in adult participants with relapsed and/or refractory follicular lymphoma (FL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
IXAZOMIB
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
14 sitesin 4 countries
Study dates
31 Oct 2013to 23 Mar 2017
Phase
Phase 2
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

  • Male or female participants 18 years or older.
  • Participants must have a pathologically confirmed diagnosis of non-Hodgkin lymphoma (NHL) (for the lead-in dose-finding phase) and FL (for phase 2).
  • Participants must have radiographically or clinically measurable disease.
  • Participants must be relapsed and/or refractory after at least 1 prior therapy (excluding radiation) with documented progressive disease at the time of enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence.
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  • Male participants who agree to practice effective barrier contraception or agree to practice true abstinence.
  • Voluntary written consent.
  • Suitable venous access.
  • Appropriate clinical laboratory values as defined in the protocol.
  • Recovered from toxicities of prior anticancer therapy.
  • If the trial proceeds to the second step on the basis of the tandem 2-step design, participants must be confirmed PSMB1 positive at the central laboratory before treatment.

Who cannot join

  • Peripheral neuropathy that is greater or equal to Grade 2 or Grade 1 with pain.
  • Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
  • Autologous stem cell transplant within 6 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time.
  • Major surgery within 14 days before the first dose of study drug.
  • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
  • Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participants inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
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  • Evidence of current uncontrolled cardiovascular conditions including uncontrolled hypertension, severe uncontrolled ventricular arrhythmias, unstable angina, New York Heart Association (NYHA) Class III or IV cardiac disease, or myocardial infarction within the past 6 months.
  • Diarrhea greater than (>) Grade 1 on the basis of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.
  • Systemic antineoplastic (including glucocorticoids > the equivalent of 15 mg of prednisone daily), experimental, or radiation therapy within 21 days before the first dose of study drug.
  • Prior treatment with rituximab or other unconjugated antibody treatment within 42 days (21 days if clear evidence of progressive disease or immediate treatment is mandated).
  • Treatment with radioimmunoconjugates or toxin immunoconjugates within 12 weeks before the first dosing of study treatment.
  • Systemic treatment with strong inhibitors of Cytochrome P450 1A2 (CYP1A2) or Cytochrome P450 3A (CYP3A), or strong CYP3A inducers within 14 days before the first dose of IXAZOMIB - Ongoing systemic therapy with corticosteroids.
  • Central nervous system (CNS) involvement that is clinically uncontrolled or newly diagnosed in the last 4 months.
  • Ongoing or active systemic viral infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus or known active hepatitis C virus.
  • Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ.
  • Platelet transfusions within 3 days before the 1st dose of study drug.
  • Inability to swallow capsules, or inability or unwillingness to avoid taking anything by mouth except for water and prescribed medication for 2 hours before and 1 hour after dose of IXAZOMIB - Known allergy to boron or excipients in the formulation.

Trial locations and contacts

14 sites in 4 countries.

14 sites in 4 countries

United Kingdom6 sites

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Newcastle upon Tyne

  • Study site

    Plymouth

  • Study site

    Southampton

  • Study site

    Sutton

Other trials in United Kingdom

United States4 sites

  • Study site

    Boston, Massachusetts

  • Study site

    Houston, Texas

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

Other trials in United States

Belgium3 sites

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Wilrijk

Other trials in Belgium

Canada1 site

  • Study site

    Montreal, Quebec

Other trials in Canada

About this study

Official title: An Open-label, Multicenter, Phase 2 Study of Oral IXAZOMIB (MLN9708) in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma

The primary purpose of this study is to evaluate the anti-tumor activity of oral Ixazomib as measured by overall response rate (ORR) in adult participants with relapsed and/or refractory follicular lymphoma (FL).

Being tested
IXAZOMIB
Keywords
MLN9708, Lymphoma, IXAZOMIB
Medical subject headings
Lymphoma, Follicular, Lymphoma

What participants receive

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

  • IXAZOMIBDrug

    Also called MLN9708

    Each 28-day treatment cycle will include oral administration of IXAZOMIB on Days 1, 8, and 15 followed by a rest period of 13 days.

Study groups in NCT01939899
Study groupRoleWhat they receive
IXAZOMIBExperimentalIxazomib 4, 5.3 and 7 milligram (mg), orally, once on Days 1, 8 and 15 in a 28 day treatment cycle followed by a rest period of 13 days, for up to Cycle 29 or until disease progression or unacceptable toxicity at lead-in phase for participants with NHL. After completion of lead-in phase, participants will continue into Phase 2. Participants in Phase 2 will receive Ixazomib at RP2D dose, orally, once weekly on Days 1, 8 and 15 in a 28 day treatment cycle followed by a rest period of 13 days , for up to Cycle 29 or until disease progression or unacceptable toxicity in Phase 2 for participants with RRFL.
Receives: Drug: IXAZOMIB

What is being measured

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

  1. Number of Participants With Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using the international Working Group criteria for participants CR: disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.

    Measured: Baseline up to Day 15 Cycle 29 (approximately up to Day 802) or until PD or the start of alternate therapies

Secondary outcomes (10)

  1. Lead-in Dose Finding Phase: Recommended Phase 2 Dose (RP2D)

    Measured: Baseline up to Cycle 1 Day 28

  2. Progression Free Survival (PFS)

    PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death. Participants without documentation of PD will be censored at the date of last response assessment that is SD or better. Participants without response assessment will be censored at the date of first dose.

    Measured: Time from the date of first dose of study treatment to the date of first documented PD or death (approximately up to Day 802)

  3. Phase 2: Rate of Disease Control

    Rate of disease control is defined as percentage of participants who achieved a SD or better for greater than or equal to (>=) 6 months.

    Measured: Baseline or until occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 805)

  4. Time to Response (TTR)

    TTR is defined as the time from the date of first dose of study treatment to the date of the first documentation of a PR or better response in a participant who responded.

    Measured: Time from the date of first dose of study treatment to the date of first documented PR or better response or death (approximately up to Day 802)

  5. Duration of Response (DOR)

    The DOR is defined as the time from the date of first documentation of a response to the date of first documented PD. Responders without documentation of PD will be censored at the date of last response assessment. DOR was categorized as CR+PR and CR.

    Measured: Time from the date of first documentation of a response to the date of first documented PD (approximately up to Day 802)

  6. Phase 2: Number of Participants With Response Rates in PSMB1 Positive and PSMB1 Negative

    Measured: Baseline up to occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 802)

  7. Number of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Baseline up to 30 days after last dose of study drug (approximately up to Day 832)

  8. Lead-in Dose Finding Phase: Cmax: Maximum Observed Plasma Concentration for Ixazomib

    Measured: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose

  9. Lead-in Dose Finding Phase: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

    Measured: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose

  10. Lead-in Dose Finding Phase: AUC(0-168): Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Postdose for Ixazomib

    Measured: Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose

Timeline

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

  1. First posted11 Sep 2013 (estimated)
  2. Study start31 Oct 2013
  3. Primary completion1 Jun 2016
  4. Study completion23 Mar 2017

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939899
Sponsor's protocol ID
C16017
Other IDs
2013-002302-32, U1111-1164-7551, 166547, REec-2016-2137, 13/EM/0373
Status last verified
Oct 2019
First submitted
28 Aug 2013
Last updated
29 Oct 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IXAZOMIB in people with Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 14 sites in 4 countries.

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 12 inclusion and 17 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 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United Kingdom, United States, Belgium, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 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?

Number of Participants With Overall Response Rate (ORR) (time frame: Baseline up to Day 15 Cycle 29 (approximately up to Day 802) or until PD or the start of alternate therapies). 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 NCT01939899.

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 29 Oct 2019.

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