Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004503

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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 patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a
single-agent comparator in countries that do not permit its use at this time.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004503
  •   2012/11/20
  •   2011/11/28
  •   no
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Secondary IDs

  •   2011-003545-18 
  •   NCT01482962  (ClinicalTrials.gov)
  •   C14012  (Millennium Pharmaceuticals, Inc.)
  •   2011-003545-18 
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Health Condition or Problem studied

  •   Relapsed Peripheral T-Cell Lymphoma
  •   Refractory Peripheral T-Cell Lymphoma
  •   C84.4 -  Peripheral T-cell lymphoma
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Interventions/Observational Groups

  •   Drug: Alisertib
  •   Drug: Pralatrexate
  •   Drug: Gemcitabine
  •   Drug: Romidepsin
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Number of patients with overall response; time frame: Change from screening period in response assessed 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; Overall response rate (ORR) by central review + progression free survival (PFS)
- Number of patients with PFS; time frame: Change from screening period in response assessed 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; Based on IRC assessment using a modified IWG (2007) criteria

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Secondary Outcome

- Number of patients with complete response + complete response unconfirmed; time frame: Response assessed 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
- Number of patients with overall survival; time frame: Patients will be followed for survival for 2 years from date of last patient off study, or death, whichever occurs first. Contacts will be every 4 months.
- Time to disease progression, duration of response, and time to response; time frame: 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.
- Number of adverse events, serious adverse events, assessments of clinical laboratory values and clinically important abnormalities, and vital sign measurements; time frame: For each patient, from screening period to 30 days after last dose of study drug, approximately 1 year; Safety and tolerability of alisertib
- Time to subsequent antineoplastic therapy; time frame: From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years
- Plasma concentration-time data to contribute to future population pharmacokinetics (PK) analysis; time frame: Cycle 1, Days 1&7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration approximately 4 months.
- Changes in reported symptoms and Quality of Life (QOL) assessment per Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) for functioning and symptoms; time frame: At screening period; Day 1 of each cycle; End of Treatment; Progression Free Survival follow-up. Duration approximately 3 years.

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Countries of Recruitment

  •   United States
  •   Canada
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2012/06/30
  •   354
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria:

- Male or female patients age 18 or older

- Patients with PTCL according to World Health Organization (WHO) criteria and have
relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL.
Patients must have received conventional therapy as a prior therapy. Cutaneous-only
disease is no permitted. Patients must have documented evidence of progressive
disease.

- Tumor biopsy available for central hematopathologic review

- Measurable disease according to the IWG criteria

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

- Female patients 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 patients 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

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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

- Patients 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

- Patients 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 patient must have recovered to National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to patients'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 patients 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

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Addresses

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    • Millennium Pharmaceuticals, Inc.
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    • Millennium Pharmaceuticals, Inc.
    • Medical Monitor 
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    • For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.