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A Study of Pevonedistat in Combination With Select Standard of Care Agents in Participants With Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myelogenous Leukemia, Or Advanced Solid Tumors With Severe Renal Impairment or Mild or Moderate Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT03814005
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to characterize the pharmacokinetic (PK) of pevonedistat in participants with severe renal impairment or mild or moderate hepatic impairment.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Acute Renal Insufficiency Liver Disease Neoplasms Drug: Azacitidine Drug: Pevonedistat Drug: Docetaxel Drug: Paclitaxel Drug: Carboplatin Phase 1

Detailed Description:

The drug being tested in this study is called pevonedistat. The study will characterize the PK of pevonedistat, assess the safety, and determine the dose of pevonedistat, in combination with azacitidine, docetaxel OR paclitaxel plus carboplatin in participants with higher-risk myelodysplastic syndromes (HRMDS), myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), acute myelogenous leukemia (AML), or advanced solid tumors who also have severe renal impairment or mild or moderate hepatic impairment.

The study will enroll approximately 42 participants. Participants with solid tumors or hematologic malignancies will be assigned to one of the four treatment groups on the basis of their renal and hepatic function:

  • Control Arm (Normal Renal and Hepatic Function)
  • Renal Arm (Severe Renal Impairment)
  • Mild Hepatic Arm (Mild Hepatic Impairment)
  • Moderate Hepatic Arm (Moderate Hepatic Impairment)

The study will be conducted in 2 parts: Part A and Part B. Part A will include single dose administration of pevonedistat. Eligible participants from Part A who will opt to continue treatment in Part B will be treated with pevonedistat in combination with standard of care (SOC) agents (azacitidine, docetaxel OR paclitaxel plus carboplatin) in Part B.

Dose escalation of pevonedistat and SOC agents will be based on the safety data from Cycle 1 of Part B as mentioned below:

  • In renal arm (severe renal impairment ) based on the safety data from Cycle 1 of Part B, pevonedistat may be increased to 15 mg/m^2 on Days 1, 3, and 5 of Cycle 2 Part B and in subsequent Cycles, to a maximum dose of 25 mg/m^2. Participants may be eligible for intrapatient dose escalation to paclitaxel 175 mg/m^2 in Cycle 2 or beyond if the lower dose is well tolerated. Intrapatient dose escalation of carboplatin to AUC5 will be allowed if treatment with AUC4 in Cycle 1 of Part B is safe and tolerable.
  • In mild hepatic arm (mild hepatic impairment), the starting dose for pevonedistat and azacitidine in combination are not escalated in the cohort. Intrapatient dose escalation of carboplatin to AUC5 will be allowed if treatment with AUC4 in Cycle 1 of Part B is safe and tolerable.
  • In moderate hepatic arm (moderate hepatic impairment) based on the safety data from Cycle 1 of Part B, pevonedistat may be increased to 15 mg/m^2 on Days 1, 3, and 5 of Cycle 2 Part B and in subsequent Cycles, to a maximum dose of 20 mg/m^2. Intrapatient dose escalation of carboplatin to AUC5 will be allowed if treatment with AUC4 in Cycle 1 of Part B is safe and tolerable.

This multi-center trial will be conducted in the United States and Spain. The overall time to participate in this study is approximately 3.5 years. Participants will attend end of the study visit 30 days after the last dose of study drug or before the start of subsequent therapy, if that occurs sooner for safety follow up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1/1b Study of Pevonedistat in Combination With Select Standard of Care Agents in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myelogenous Leukemia, or Advanced Solid Tumors With Severe Renal Impairment or Mild or Moderate Hepatic Impairment
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : October 4, 2021
Estimated Study Completion Date : February 22, 2022


Arm Intervention/treatment
Experimental: Control Arm (Normal Renal and Hepatic Function)
Pevonedistat 20 milligram per square meter (mg/m^2), infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously, once on Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Drug: Azacitidine
Azacitidine subcutaneous injection.

Drug: Pevonedistat
Pevonedistat intravenous infusion.
Other Name: TAK-924 and MLN4924

Experimental: Renal Arm (Severe Renal Impairment)
Pevonedistat 20 mg/m^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies or solid tumors, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously, once on Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 15 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies and docetaxel 75 mg/m^2 OR carboplatin AUC4, infusion, intravenously, once along with paclitaxel 135 mg/m^2, infusion, intravenously, once on Day 1 in combination with pevonedistat 15 mg/m^2, infusion, intravenously, on Days 3 and 5 in each 21-day treatment cycle in participants with solid tumors until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Drug: Azacitidine
Azacitidine subcutaneous injection.

Drug: Pevonedistat
Pevonedistat intravenous infusion.
Other Name: TAK-924 and MLN4924

Drug: Docetaxel
Docetaxel intravenous infusion.

Drug: Paclitaxel
Paclitaxel intravenous infusion.

Drug: Carboplatin
Carboplatin intravenous infusion.

Experimental: Mild Hepatic Arm (Mild Hepatic Impairment)
Pevonedistat 20 mg/m^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies or solid tumors, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously, once on Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies, and carboplatin AUC4, infusion, intravenously, once along with paclitaxel 135 mg/m^2, infusion, intravenously, once on Day 1 in combination with pevonedistat 20 mg/m^2, infusion, intravenously, on Days 3 and 5 in each 21-day treatment cycle in participants with solid tumors until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Drug: Azacitidine
Azacitidine subcutaneous injection.

Drug: Pevonedistat
Pevonedistat intravenous infusion.
Other Name: TAK-924 and MLN4924

Drug: Paclitaxel
Paclitaxel intravenous infusion.

Drug: Carboplatin
Carboplatin intravenous infusion.

Experimental: Moderate Hepatic Arm (Moderate Hepatic Impairment)
Pevonedistat 20 mg/m^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies or solid tumors, followed by a washout period of approximately 4 to 7 days, further followed by azacitidine 75 mg/m^2, injection, subcutaneously, once on Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 10 mg/m^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies, and carboplatin AUC4, infusion, intravenously, once along with paclitaxel 90 mg/m^2, infusion, intravenously, once on Day 1 in combination with pevonedistat 10 mg/m^2, infusion, intravenously, on Days 3 and 5 in each 21-day treatment cycle in participants with solid tumors until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Drug: Azacitidine
Azacitidine subcutaneous injection.

Drug: Pevonedistat
Pevonedistat intravenous infusion.
Other Name: TAK-924 and MLN4924

Drug: Paclitaxel
Paclitaxel intravenous infusion.

Drug: Carboplatin
Carboplatin intravenous infusion.




Primary Outcome Measures :
  1. Part A, AUC∞: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity for Pevonedistat Following a Single Dose [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  2. Part A, AUClast: Area Under the Plasma Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration for Pevonedistat Following a Single Dose [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  3. Part A, Cmax: Maximum Observed Plasma Concentration for Pevonedistat Following a Single Dose [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]

Secondary Outcome Measures :
  1. Parts A and B, t1/2z: Terminal Disposition Phase Half-life for Pevonedistat Following Single and Multiple Dose [ Time Frame: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle (C ) 1 Day (D) 3 pre-dose and at multiple time points (up to 48 hours) post-dose (C length =28 D [hematologic malignancies], and =21 D [solid tumors]) ]
  2. Part B, Cmax: Maximum Observed Plasma Concentration for Pevonedistat Following Multiple Dose [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors] ]
  3. Parts A and B, fu: Fraction of Unbound Drug in Plasma for Pevonedistat [ Time Frame: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle (C) 1 Day (D) 3 pre-dose and at multiple time points (up to 48 hours) post-dose (C length =28 D [hematologic malignancies], and =21 D [solid tumors] ]
  4. Part B, Cmax: Maximum Observed Plasma Concentration for Azacitidine Following Multiple Dose [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length is equal to [=] 28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  5. Part B, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Azacitidine Following Multiple Dose [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  6. Part B, t1/2z: Terminal Disposition Phase Half-life for Azacitidine Following Multiple-dose [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length = 28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  7. Part B, AUCτ: Area under the Concentration-time Curve from Time Zero to the end of the Dosing Interval for Pevonedistat and Azacitidine Following Multiple Dose [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  8. Parts A and B, CL: Total Clearance for Pevonedistat [ Time Frame: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle (C) 1 Day (D) 3 pre-dose and at multiple time points (up to 48 hours) post-dose (C length =28 D [hematologic malignancies], and =21 D [solid tumors] ]
  9. Part B, CL/F: Apparent Clearance for Azacitidine [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  10. Part B, CLR: Renal Clearance for Pevonedistat [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  11. Part B, CLR: Renal Clearance for Azacitidine [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  12. Parts A and B, Vss: Volume of Distribution at Steady-state of Pevonedistat [ Time Frame: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle (C) 1 Day (D) 3 pre-dose and at multiple time points (up to 48 hours) post-dose (C length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  13. Part B, Vss: Apparent Volume of Distribution of Azacitidine [ Time Frame: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
  14. Part B, Percentage of AML Participants with Complete Response (CR) or Partial Response (PR) [ Time Frame: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles or as per the discretion of the investigator (up to 3.5 years) (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
    Disease response in AML are based on international working group (IWG) for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in AML. For AML participants, all CR includes both CR and complete remission with incomplete blood count recovery (Cri). CR: morphologic leukemia-free state with absolute neutrophil count (ANC) of greater than (>) 1000 per microliter (/mcL) and platelets of greater than or equal to (>=) 100,000/mcL, and no residual evidence of extramedullary leukemia. Cri: After chemotherapy, some participants fulfill all criteria for CR except for residual neutropenia (less than [<] 1000/mcL) or thrombocytopenia (<100,000/mcL). PR: requires all hematologic values for a CR but with a decrease of at least 50 percent (%) in the percentage of blasts to 5% to 25% in the bone marrow aspirate. A value of less than or equal to (<=) 5% blasts may also be considered a PR if Auer rods are present.

  15. Part B, Percentage of MDS and CMML Participants with CR, PR or Hematologic Improvement (HI) [ Time Frame: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles or as per the discretion of the investigator (up to 3.5 years) (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
    Disease response in MDS and CMML will be based on best overall response (CR+PR+HI) as determined by investigator using revised IWG response criteria for MDS and CMML.

  16. Part B, Percentage of AML Participants with Overall Response [ Time Frame: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles or as per the discretion of the investigator (up to 3.5 years) (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
    Overall response is CR, PR, or HI and will be determined by using the revised IWG response criteria.

  17. Part B, Duration of CR, PR and HI [ Time Frame: From first documentation of response up to disease progression ( up to 3.5 years) ]
    Duration of response in participants with disease response (CR+PR+HI) for hematologic malignancies is time between first documentation of response and disease progression. Duration of response will be determined by the investigator using the revised IWG response criteria. The duration of response in participants with disease response (CR+PR) for solid tumors is time between the first documentation of response and the first documentation of progressive disease (PD) or death if no prior PD is documented. Duration of response will be determined by investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

  18. Part B, Percentage of Solid Tumors Participants with CR or PR [ Time Frame: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles or as per the discretion of the investigator (up to 3.5 years) (Cycle length =28 days [hematologic malignancies], and =21 days [solid tumors]) ]
    Disease response in solid tumors will be based on best overall response (CR+PR) as determined by investigator using the RECIST version 1.1 criteria. CR: disappearance of all target lesions with any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeter (mm) and disappearance of all nontarget lesions and normalization of tumor marker level with all lymph nodes must be nonpathological in size (<10 mm short axis); PR: At least a 30% decrease from baseline in the sum of diameters of target lesions, taking as reference the baseline sum of diameters and Persistence of one or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All participants:

  1. Has expected survival of at least 3 months from the date of enrollment in the study.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  3. Has recovered (that is, Grade <=1 toxicity) from the reversible effects of prior anticancer therapy.
  4. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <=1.5 * upper limit of the normal range (ULN) at screening or within 7 days before the first dose of study drug.
  5. Suitable venous access for the study-required blood sampling (that is, PK sampling).

    For hematologic malignancies:

  6. Morphologically confirmed diagnosis of MDS or nonproliferative CMML (that is, with white blood cell [WBC] <13,000 /mcL) at the study entry, based on one of the following:

    French-American-British (FAB) Classifications:

    • Refractory anemia with excess blasts (RAEB), defined as having 5% to 20% myeloblasts in the bone marrow.
    • CMML with 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood. OR

    world health organization (WHO) Classifications:

    • RAEB-1, defined as having 5% to 9% myeloblasts in the bone marrow.
    • RAEB-2, defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood.
    • CMML-2, defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood.
    • CMML-1 (although CMML-1 is defined as having <10% myeloblasts in the bone marrow and/or <5% blasts in the blood, these participants may enroll only if bone marrow blasts >=5%).

    With MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R):

    • Very high (>6 points).
    • High (>4.5-6 points).
    • Intermediate (>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts.
  7. With WHO-defined AML at study entry, including leukemia secondary to prior chemotherapy or resulting from an antecedent hematologic disorder, have failed to achieve CR or have relapsed after prior therapy and are not candidates for potentially curative treatment.
  8. With relapsed or refractory MDS, have previously been treated with an hypomethylating agent.
  9. Laboratory value requirements per study arms are:

    • Estimated glomerular filtration rate (eGFR) (milliliter per minute per 1.73 square meter [mL/min/1.73^m]) >=90 (Control arm), <30 (Renal arm) , >=60 (Mild and Moderate hepatic arm).
    • Total Bilirubin <= ULN (Control arm), <= ULN (Renal arm), ULN <Bilirubin <=1.5 * ULN (not secondary to transfusions) (Mild hepatic arm) and 1.5 * ULN <bilirubin <=3.0 * ULN (not secondary to transfusions) (Moderate hepatic arm).
    • Alanine aminotransferase (ALT) <= ULN (Control arm), <=2.5 * ULN (Renal arm) and any value (for mild and moderate hepatic arm).

    For advanced solid tumors:

  10. Have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with pevonedistat in combination with either docetaxel or carboplatin plus paclitaxel in Part B of this study, or have progressed despite standard therapy, or whom conventional therapy is not considered effective.
  11. Computerized tomography (CT) scan or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis within 28 days of the first dose of the study drug.
  12. Laboratory value requirements per study arms are:

    • eGFR (mL/min/1.73m^2) <30 (Renal arm) and >=60 (mild and moderate hepatic arm).
    • Total bilirubin <=ULN (Renal arm), ULN <bilirubin <=1.5 * ULN (Mild hepatic arm) and 1.5 * ULN <bilirubin <=3.0 * ULN (Moderate hepatic arm).
    • ALT <=1.5 * ULN (for participants who receive pevonedistat plus docetaxel only) or <=2.5 * ULN (for participants who receive pevonedistat plus carboplatin plus paclitaxel only) (Renal arm) and any value (Mild and Moderate hepatic arm).

Exclusion Criteia:

All participants:-

  1. Participants with end-stage renal disease requiring hemodialysis.
  2. Has Gilbert syndrome.
  3. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia. Prophylactic treatment with antibiotics is allowed.
  4. Has life-threatening illness unrelated to cancer.
  5. Known human immunodeficiency virus (HIV) seropositive.
  6. Has left ventricular ejection fraction (LVEF) <50% within 6 months prior to study enrollment. If a result within this time frame is unavailable, LVEF must be determined by echocardiography at screening.
  7. Has severe uncontrolled ventricular arrhythmias or torsade de pointes; electrocardiographic evidence of acute ischemia or active conduction system abnormalities; or clinically significant arrhythmia (as an example, well-controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion).
  8. Has severe symptomatic pulmonary hypertension requiring pharmacologic therapy or participants with chronic respiratory disease that requires continuous oxygen.

    For hematologic malignancies:

  9. Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis.
  10. With AML with a WBC count >=50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they otherwise meet the eligibility criteria.
  11. With either clinical evidence of or history of central nervous system (CNS) involvement by AML.
  12. With hematologic malignancies, PT or aPTT >1.5 * ULN or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment.

    For advanced solid tumors:

  13. Has prior treatment with radiation therapy involving >=25% of the hematopoietically active bone marrow.
  14. Has CNS metastasis, except for participants who have received prior treatment (radiation or resection) and have stable CNS disease (example: stable MRI, no steroid requirement).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814005


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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United States, California
Compassionate Cancer Care Medical Group Inc Recruiting
Fountain Valley, California, United States, 92708
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Spain
Hospital Universitario Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 8916
ICO lHospitalet Hospital Duran i Reynals Recruiting
LHospitalet de Llobregat, Barcelona, Spain, 8908
Hospital Universitario Vall d'Hebron - PPDS Recruiting
Barcelona, Spain, 8035
Hospital de San Pedro de Alcantara Recruiting
Caceres, Spain, 10003
C.H. Regional Reina Sofia Recruiting
Cordoba, Spain, 14004
Complejo Asistencial Universitario de Salamanca H. Clinico Recruiting
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocio - PPDS Recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Millennium Pharmaceuticals, Inc.
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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03814005    
Other Study ID Numbers: Pevonedistat-1016
U1111-1220-1396 ( Other Identifier: WHO )
2018-004049-17 ( EudraCT Number )
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug therapy
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Leukemia, Myelomonocytic, Acute
Liver Diseases
Renal Insufficiency
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Paclitaxel
Docetaxel
Carboplatin
Azacitidine
Pevonedistat
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators