NCT01939899

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 29, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

2.6 years

First QC Date

August 28, 2013

Results QC Date

March 20, 2018

Last Update Submit

October 7, 2019

Conditions

Follicular Lymphoma

Keywords

MLN9708LymphomaIXAZOMIB

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

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

    Baseline up to Cycle 1 Day 28

  • Progression Free Survival (PFS)

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

  • Phase 2: Rate of Disease Control

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

  • Time to Response (TTR)

    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)

  • Duration of Response (DOR)

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

  • +5 more secondary outcomes

Study Arms (1)

IXAZOMIB

EXPERIMENTAL

Ixazomib 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.

Drug: IXAZOMIB

Interventions

IXAZOMIBDRUG

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.

Also known as: MLN9708
IXAZOMIB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Unknown Facility

Southampton, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma

Interventions

ixazomib

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Medical Director
Organization
Millennium Pharmaceuticals, Inc.
globaloncologymedinfo@takeda.com
+1-844-662-8532

Study Officials

  • Medical Director

    Millennium Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 11, 2013

Study Start

October 31, 2013

Primary Completion

June 1, 2016

Study Completion

March 23, 2017

Last Updated

October 29, 2019

Results First Posted

October 29, 2019

Record last verified: 2019-10

Locations

CA(1)GB(6)BE(3)US(4)