Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Millennium Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01939899
First received: August 28, 2013
Last updated: November 18, 2014
Last verified: November 2014

August 28, 2013
November 18, 2014
November 2013
June 2016   (final data collection date for primary outcome measure)
Overall Response (Complete Response (CR) + Partial Response(PR)) Rate (ORR) [ Time Frame: Time from the start of treatment to the occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (up to approximately 24 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01939899 on ClinicalTrials.gov Archive Site
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Approximately 8 months after dosing the first patient ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death ] [ Designated as safety issue: No ]
  • Rate of Disease Control [ Time Frame: Time from the start of treatment to the occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (up to approximately 24 months) ] [ Designated as safety issue: No ]
  • Time to Response (TTR) [ Time Frame: Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR (assessed up to approximately 24 months) ] [ Designated as safety issue: No ]
  • Duration of Response (DOR) [ Time Frame: Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented (assessed up to approximately 24 months) ] [ Designated as safety issue: No ]
  • Response rates in FL patients positive versus negative for the proteasome subunit beta type-1 (PSMB1) polymorphic marker [ Time Frame: Time from the start of treatment to the occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (up to approximately 24 months) ] [ Designated as safety issue: No ]
  • Number of participants with Adverse Events (AE) or Serious Adverse Events (SAE) [ Time Frame: Signing of informed consent through 30 days after last dose ] [ Designated as safety issue: Yes ]
  • Plasma PK parameters including Maximum Concentration (Cmax), Single-dose time to reach maximum plasma concentration (Tmax), Area under the plasma concentration versus time curve (AUC) from zero to time of last quantifiable plasma concentration (AUClast) [ Time Frame: Days 1-3, 5, 8, 15-17, 19 and 22 during Cycle 1 and Day 1 during Cycles 2-4 of each lead-in dose finding cohort ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 2 Study of Oral IXAZOMIB in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma
An Open-label, Multicenter, Phase 2 Study of Oral IXAZOMIB (MLN9708) in Adult Patients With Relapsed and/or Refractory Follicular Lymphoma

This is an open-label, multicenter, phase 2 study to evaluate the efficacy and safety of oral IXAZOMIB in adult patients with follicular lymphoma (FL) that is relapsed and/or refractory to prior treatment.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Follicular Lymphoma
Drug: IXAZOMIB
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.
Experimental: IXAZOMIB
Intervention: Drug: IXAZOMIB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
March 2018
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients 18 years or older
  • Patients must have a pathologically confirmed diagnosis of non-Hodgkin lymphoma (NHL) (for the lead-in dose-finding phase) and FL (for phase 2)
  • Patients must have radiographically or clinically measurable disease
  • Patients 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 patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence
  • Male patients 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, patients must be confirmed PSMB1 positive at the central laboratory before treatment

Exclusion Criteria

  • Peripheral neuropathy that is greater or equal to Grade 2 or Grade 1 with pain
  • Female patients 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 patient 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 > Grade 1 on the basis of the 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 CYP1A2 or 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
Both
18 Years and older
No
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com
United States,   Belgium,   Canada,   United Kingdom
 
NCT01939899
C16017, 2013-002302-32
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP