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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01482962




Registration number
NCT01482962
Ethics application status
Date submitted
28/11/2011
Date registered
1/12/2011
Date last updated
31/07/2018

Titles & IDs
Public title
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
Scientific title
A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Secondary ID [1] 0 0
2011-003545-18
Secondary ID [2] 0 0
C14012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed Peripheral T-Cell Lymphoma 0 0
Refractory Peripheral T-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alisertib
Treatment: Drugs - Pralatrexate
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Romidepsin

Experimental: Alisertib - Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).

Active Comparator: Pralatrexate, or Romidepsin, or Gemcitabine - Pralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).


Treatment: Drugs: Alisertib
Alisertib enteric coated tablets

Treatment: Drugs: Pralatrexate
Pralatrexate IV infusion

Treatment: Drugs: Gemcitabine
Gemcitabine IV infusion

Treatment: Drugs: Romidepsin
Romidepsin IV infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment - ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.
Timepoint [1] 0 0
Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
Primary outcome [2] 0 0
Progression-Free Survival (PFS) Based on IRC Assessment - PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first.
Timepoint [2] 0 0
Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
Secondary outcome [1] 0 0
Overall Survival (OS) - OS was defined as the time from the date of randomization to the date of death. Participants without documentation of death were censored at the date last known to be alive.
Timepoint [1] 0 0
Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm)
Secondary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) - An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event.
Timepoint [2] 0 0
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Secondary outcome [3] 0 0
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs - Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.
Timepoint [3] 0 0
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Secondary outcome [4] 0 0
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs - Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.
Timepoint [4] 0 0
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Secondary outcome [5] 0 0
Complete Response (CR) Rate - Complete Response (CR) rate is defined as the percentage of participants with CR as assessed by the IRC using IWG criteria (2007 Cheson). CR= Disappearance of all evidence of disease.
Timepoint [5] 0 0
At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years)
Secondary outcome [6] 0 0
Time to Disease Progression (TTP) - Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse.
Timepoint [6] 0 0
At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
Secondary outcome [7] 0 0
Duration of Response (DOR) - DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better.
Timepoint [7] 0 0
At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
Secondary outcome [8] 0 0
Time to Response - Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better.
Timepoint [8] 0 0
At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
Secondary outcome [9] 0 0
Time to Subsequent Antineoplastic Therapy - Time to subsequent antineoplastic therapy was defined as the time from randomization to the first date of subsequent antineoplastic therapy (excluding transplant). Participants without subsequent antineoplastic therapy were censored at the date of death or last known to be alive.
Timepoint [9] 0 0
From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years
Secondary outcome [10] 0 0
Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis
Timepoint [10] 0 0
Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months.
Secondary outcome [11] 0 0
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms - The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement.
Timepoint [11] 0 0
Baseline and End of Treatment (EOT) (Up to 152 Weeks)

Eligibility
Key inclusion criteria
- Male or female participants age 18 or older

- Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to
World Health Organization (WHO) criteria and have relapsed or are refractory to at
least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received
conventional therapy as a prior therapy. Cutaneous-only disease is not permitted.
Participants must have documented evidence of progressive and measurable disease.

- Tumor biopsy available for central hematopathologic review

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Female participants who are post menopausal for at least 1 year, surgically sterile,
or agree to practice 2 effective methods of contraception through 30 days after the
last dose of study drug or agree to abstain from heterosexual intercourse.

- Male participants who agree to practice effective barrier contraception through 6
months after the last dose of alisertib or agree to abstain from heterosexual
intercourse

- Suitable venous access

- Voluntary written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Known central nervous system lymphoma

- Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation
therapy within 4 weeks of first dose of study treatment or concomitant use during
study

- Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all
of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known
hypersensitivity)

- History of uncontrolled sleep apnea syndrome or other conditions that could result in
excessive daytime sleepiness

- Cardiac condition as specified in study protocol, including left ventricular ejection
fraction (LVEF) <40%

- Concomitant use of other medicines as specified in study protocol

- Participants with abnormal gastric or bowel function who require continuous treatment
with H2-receptor antagonists or proton pump inhibitors

- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or
hepatitis C

- Autologous stem cell transplant less than 3 months prior to enrollment

- Participants who have undergone allogeneic stem cell or organ transplantation any time

- Inadequate blood levels, bone marrow or other organ function as specified in study
protocol

- The participant must have recovered to National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE) Grade = 1 toxicity, to participant's baseline
status (except alopecia), or deemed irreversible from the effects of prior cancer
therapy

- Major surgery, serious infection, or infection requiring systemic antibiotic therapy
within 14 days prior to the first dose of study treatment

- Female participants who are breastfeeding or pregnant

- Coexistent second malignancy or history of prior solid organ malignancy within
previous 3 years

- Serious medical or psychiatric illness or laboratory abnormality that could, in the
investigator's opinion, potentially interfere with the completion of treatment
according to the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- Gosford
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- St Leonards
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
- St Leonards
Recruitment outside Australia
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Alabama
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California
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Indiana
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ULM
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Braga
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Moscow
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Petrozavodsk
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Pamplona
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Salamanca
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Sevilla
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Spain
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Valencia
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Sweden
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Linkoping
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Sweden
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Lund
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Sweden
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Solna
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Turkey
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Ankara
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Turkey
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Denizli
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Turkey
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Istanbul
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Turkey
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Kayseri
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Turkey
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Samsun
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United Kingdom
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Southampton
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United Kingdom
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Millennium Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib
compared with single-agent treatment, as selected by the investigator from the offered
options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or
refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent
comparator outside the United States of America (USA) as supply was not available.
Trial website
https://clinicaltrials.gov/show/NCT01482962
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Takeda Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications