A Phase 3 Trial of Alisertib (MLN8237) or Investigator's Choice (SelectedSingle Agent) in Patients With Relapsed or Refractory Peripheral T-CellLymphoma.

Phase 1

Conditions: Relapsed or Refractory Peripheral T-Cell Lymphoma
MedDRA version: 17.0Level: PTClassification code 10034629Term: Peripheral T-cell lymphoma unspecified stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10034628Term: Peripheral T-cell lymphoma unspecified stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10034627Term: Peripheral T-cell lymphoma unspecified stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10034626Term: Peripheral T-cell lymphoma unspecified refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10034625Term: Peripheral T-cell lymphoma unspecified recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10034630Term: Peripheral T-cell lymphoma unspecified stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10034623Term: Peripheral T-cell lymphoma unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-003545-18-NL

Lead Sponsor: Millennium Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 271

Inclusion Criteria

- Male or female patients age 18 or older
- Patients with PTCL according to World Health Organization (WHO) criteria (nodal and extranodal disease subtypes) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 226

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 both of the comparator drugs (pralatrexate, 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%
- Serum potassium < 3.6 mmol/L or serum magnesium < 0.85 mmol/L
- 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 and/or chronic 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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