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Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217838
Recruitment Status : Active, not recruiting
First Posted : July 14, 2017
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), and schedule, safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 monotherapy or with combination agent(s) in relapsed/refractory acute myeloid leukaemia (AML) patients or treatment-naïve AML patients not eligible for intensive induction therapy. In addition, the study will explore the potential clinical activity by assessing anti-tumour activity in patients. There are two parts to this study: Part A, dose escalation, and Part B, dose expansion.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukaemia Drug: AZD2811 Drug: Azacitidine Drug: Venetoclax Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Multicentre 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia Patients Not Eligible for Intensive Induction Therapy.
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021


Arm Intervention/treatment
Experimental: Part A - Group 1 Arm A: Monotherapy Dose Escalation
AZD2811 single agent on Days 1 and 4 of each 28 day cycle. Dose escalation
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Experimental: Part A - Group 1 Arm B: Monotherapy Dose Escalation
AZD2811 single agent on Days 1, 4, 15, and 18 of each 28 day cycle. Dose Escalation
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Experimental: Part A - Group 2 Arm A: AZD2811 plus Azacitidine Dose Escalation
AZD2811 on Days 1 and 4 plus Azacitidine combination therapy. Escalating doses of AZD2811
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Drug: Azacitidine

Azacitidine is supplied in vials of 25 mg/mL powder for suspension for injection. After reconstitution, each vial contains a maximum of 100 mg.

Patients should be pre-medicated for nausea and vomiting according to institutional standards before receiving azacitidine. Patients will receive 75 mg/m² on Days 1 through 7 or for 5 consecutive weekdays with rest on the 2 weekend days, and azacitidine dosing the first 2 weekdays of the next week of each 28-day cycle.

Other Name: Vidaza (TM)

Experimental: Part A - Group 3 Arm A: AZD2811 plus Venetoclax Dose Escalation
AZD2811on Days 1 and 4 plus Venetoclax combination therapy. Escalating doses of AZD2811
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Drug: Venetoclax
Venetoclax (VENCLEXTA®) is approved by the FDA for use in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venetoclax is planned to be given at a dose of 100 mg orally (PO) on Day 1 and 200 mg (PO) on Days 2- 28 for the 1st cycle. The third patient in cohort 1 (AZD2811 at 200 mg) will only be enrolled after the first 2 patients have received ≥2 weeks of treatment and have shown no evidence of toxicity observed to be compatible with a DLT.
Other Name: Venclexta (TM)

Experimental: Part B - Group 1: AZD2811 Monotherapy Dose Expansion
Monotherapy dose expansion. Additional patients will be enrolled at the AZD2811 MTD in the dose/schedule that was found most tolerable and/or efficacious.
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Experimental: Part B - Group 2: AZD2811 plus Combination Drug Dose Expansion
Combination therapy (either azacitidine or venetoclax) dose expansion. Additional patients will be enrolled at the AZD2811 combination MTD based on the dose/schedule from Part A that was found to be most tolerable and/or efficacious.
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Drug: Azacitidine

Azacitidine is supplied in vials of 25 mg/mL powder for suspension for injection. After reconstitution, each vial contains a maximum of 100 mg.

Patients should be pre-medicated for nausea and vomiting according to institutional standards before receiving azacitidine. Patients will receive 75 mg/m² on Days 1 through 7 or for 5 consecutive weekdays with rest on the 2 weekend days, and azacitidine dosing the first 2 weekdays of the next week of each 28-day cycle.

Other Name: Vidaza (TM)

Drug: Venetoclax
Venetoclax (VENCLEXTA®) is approved by the FDA for use in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venetoclax is planned to be given at a dose of 100 mg orally (PO) on Day 1 and 200 mg (PO) on Days 2- 28 for the 1st cycle. The third patient in cohort 1 (AZD2811 at 200 mg) will only be enrolled after the first 2 patients have received ≥2 weeks of treatment and have shown no evidence of toxicity observed to be compatible with a DLT.
Other Name: Venclexta (TM)

Experimental: Part A - Group 2 Arm B: AZD2811 plus Azacitidine Dose Escalation
AZD2811 on Days 1, 4, 15, and 18 plus azacitidine combination therapy. Escalating doses of AZD2811
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Drug: Azacitidine

Azacitidine is supplied in vials of 25 mg/mL powder for suspension for injection. After reconstitution, each vial contains a maximum of 100 mg.

Patients should be pre-medicated for nausea and vomiting according to institutional standards before receiving azacitidine. Patients will receive 75 mg/m² on Days 1 through 7 or for 5 consecutive weekdays with rest on the 2 weekend days, and azacitidine dosing the first 2 weekdays of the next week of each 28-day cycle.

Other Name: Vidaza (TM)

Experimental: Part A - Group 3 Arm B: AZD2811 plus Venetoclax Dose Escalation
AZD2811 on Days 1, 4, 15, and 18 plus Venetoclax combination therapy. Escalating doses of AZD2811
Drug: AZD2811
AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
Other Names:
  • AZD1152 hQPA
  • AZD1152 hydroxyl-quinazoline pyrazole anilide

Drug: Venetoclax
Venetoclax (VENCLEXTA®) is approved by the FDA for use in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venetoclax is planned to be given at a dose of 100 mg orally (PO) on Day 1 and 200 mg (PO) on Days 2- 28 for the 1st cycle. The third patient in cohort 1 (AZD2811 at 200 mg) will only be enrolled after the first 2 patients have received ≥2 weeks of treatment and have shown no evidence of toxicity observed to be compatible with a DLT.
Other Name: Venclexta (TM)




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLT) [ Time Frame: From the first day of study treatment up to the last day of Cycle 1 (28 days) ]
    The maximum tolerated dose (MTD) will be determined from the incidence of dose limiting toxicities (DLTs), adverse events (AEs), and abnormal laboratory test results.

  2. Incidence of adverse events (AEs) [ Time Frame: From the first day of study treatment up to the last day of Cycle 1 (28 days) ]
    The maximum tolerated dose (MTD) will be determined from the incidence of dose limiting toxicities (DLTs), adverse events (AEs), and abnormal laboratory test results.

  3. Incidence of abnormal laboratory test results [ Time Frame: From the first day of study treatment up to the last day of Cycle 1 (28 days) ]
    The maximum tolerated dose (MTD) will be determined from the incidence of dose limiting toxicities (DLTs), adverse events (AEs), and abnormal laboratory test results.

  4. Antitumour activity of AZD2811 in patients by assessing total complete remission (CR). Total complete remission includes patients with complete remission (CR), and complete remission with incomplete recovery (CRi). [ Time Frame: Up to 6 months ]
    Total complete remission includes patients with complete remission (CR), and complete remission with incomplete recovery (CRi).


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 6 months ]
    Overall response rate is the sum of CR + CRi + PR.

  2. Complete Remission (CR) [ Time Frame: Up to 6 months. ]
    Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 10⁹/L; independent of red cell transfusions as described in Dohner H, et al. Blood. 2010;115:453-474

  3. Complete Remission with incomplete recovery (CRi) [ Time Frame: Up to 6 months. ]
    All CR criteria except for residual neutropenia (< 1.0 × 10⁹/L) or thrombocytopenia (< 100 × 10⁹/L)

  4. Partial Remission (PR) [ Time Frame: Up to 6 months. ]
    All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

  5. Overall Survival (OS) [ Time Frame: Up to 6 months ]
  6. Maximum plasma concentration of AZD2811 after single dose (Cmax) [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  7. Time to reach maximum AZD2811 plasma concentration (tmax) after single dose. [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  8. Area under the AZD2811 plasma concentration-time curve (AUC) [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  9. Area under the AZD2811 plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)]. [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  10. Terminal elimination half-life (t1/2λz) of AZD2811 [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  11. Clearance (CL) of AZD2811 [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  12. Volume of distribution (Vz) for AZD2811 [ Time Frame: Days 1 and 4 of Cycle 1 (each cycle is 28 days) ]
  13. Determine biological effective dose (BED) of AZD2811 in AML patients in Part A. [ Time Frame: Up to 6 months ]
    BED is related to a clinical sign of activity of AZD2811, e.g., a blast cell reduction of > 50% at any time after AZD2811 administration.

  14. Maximum plasma concentration of venetoclax after single dose (Cmax) [ Time Frame: Cycle 1 Day 4 (each cycle is 28 days) ]
  15. Time to reach maximum venetoclax plasma concentration (tmax) after single dose. [ Time Frame: Cycle 1 Day 4 (each cycle is 28 days) ]
  16. Area under the venetoclax plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)]. [ Time Frame: Cycle 1 Day 4 (each cycle is 28 days) ]


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.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. AML patients who have either: (a) relapsed or are refractory to standard therapies (the patient may have been treated with standard therapy prior to the diagnosis of AML e.g. for MDS), OR (b) diagnosis of AML (bone marrow blasts ≥ 20%), who are previously untreated for AML, and are not suitable for intensive induction therapy, as defined below (for AZD2811 monotherapy and HMA combination patients only i.e. inclusion criteria 1(b) may only be used to enrol a patient into Groups 1 and 2; previously untreated AML patients may not enrol into Group 3 UNLESS they fulfil inclusion criteria 1(a) above).

    Patients are unsuitable for intensive induction therapy if they are:

    • 75 years or

      • 75 years of age with clinically significant cardiac or pulmonary dysfunction unrelated to leukaemia, as reflected by at least 1 of the following criteria: Left ventricular ejection fraction (LVEF) ≤50% Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% of expected Forced expiratory volume 1(FEV1) ≤65% of expected Chronic stable angina

    any significant co-morbidities which in the opinion of the treating physician makes the patient unsuitable for intensive induction therapy. This must be documented by the study monitor.

  2. AML patients who are unlikely to demonstrate rapid progression such that they would be unable to complete the first cycle of therapy.
  3. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
  4. Aged at least 18 years
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  6. Prior treatment with hydroxyurea (up to 24 hours before study treatment) is allowed
  7. Adequate organ system function as outlined below:

    PT/PTT ≤1.5 x upper limit of normal (ULN) Total bilirubin ≤1.5 x ULN. Patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) who have serum bilirubin ≤3 x the ULN may be enrolled, unless there is evidence of hemolytic anemia Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ˂2.5 x ULN if no liver involvement or ≤5 times the ULN with liver involvement Creatinine ≤1.5 x ULN, OR calculated or measured creatinine clearance ≥50 mL/min as calculated by the Cockcroft-Gault method, OR 24-hour measured urine creatinine clearance ≥50 mL/min.

    Patients enrolled in the venetoclax combination part with a CLcr <80 mL/min (and ≥ 45 mL/min) as calculated by Cockcroft-Gault should be able to have more intensive prophylaxis and monitoring (according to institutional standard) to reduce the risk of TLS when initiating treatment with venetoclax.

  8. Females should be using adequate contraception, should not be breast feeding and must have a negative serum pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: a) Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, b) have documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

9 Sexually active male patients should be willing to use barrier contraception i.e., condoms. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential, unless the male patient is abstaining from sexual intercourse.

Exclusion criteria

  1. Treatment with any of the following:

    Any investigational agents, experimental antibody or antibody drug conjugates, or study drugs from a previous clinical study within 3-4 weeks of said prior investigational agent(s) with regard to the first dose of study treatment on this CSP

    Any other chemotherapy (except hydroxyurea), immunotherapy or anticancer agents within 2 weeks of the first dose of study treatment

    Any haematopoietic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) within 7 days of the first dose of AZD2811 monotherapy or with combination agent(s) or pegylated G-CSF (pegfilgrastim) or darbepoetin within 14 days of the first dose of study treatment

    Prescription or non-prescription drugs or other products known to be strong inhibitors/inducers of CYP3A that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Washout periods should be a minimum of 5 half-lives depending on the medication.

    Patients who have undergone allogeneic stem cell transplant within 12 months are excluded. If allogeneic transplant was >12 months ago, then they are not excluded as long as they are off all immunosuppression and have no signs or symptoms of active graft versus host disease.

    Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment

  2. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment .
  3. Presence of, or history of leptomeningeal disease.
  4. As judged by the Investigator, any evidence of: severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or other malignancy (like advanced malignant hepatic tumours); current unstable or uncompensated respiratory or cardiac conditions; or uncontrolled hypertension; history of, or active, bleeding diatheses (e.g., haemophilia or von Willebrand disease); patients with inflammatory bowel disease (e.g., Crohn or colitis ulcerosa); uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment); or IV anti-infective treatment within 2 weeks before first dose of study treatment unless either clear evidence would indicate that despite the clinical symptoms no infection took place, or just a single dose of IV antibiotics was administered followed by oral treatment thereafter.
  5. Any of the following cardiac criteria: a) Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II, b) Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, c) Unstable angina or new-onset angina, d) QTcF interval >450 ms (for male subjects) or >470 ms (for female subjects) on screening ECG.
  6. Active non-infectious skin disease (including rash, dermatitis, or psoriasis, but excluding stable plaque psoriasis from the definition of active disease). Patients with a rash that is biopsy-proven leukaemia or with pressure ulcers are not excluded. Patients with petechiae from thrombocytopenia or patients with drug related rashes that are improving are not excluded..
  7. Patients with a known hypersensitivity to azacitidine or mannitol (HMA combination patients only).
  8. History of hypersensitivity to active or inactive excipients (e.g., PEG) of any drug in the study or drugs with a similar chemical structure or class to those investigated in the study.
  9. Known history of infection with human immunodeficiency virus (HIV)
  10. Serologic status reflecting active hepatitis B or C infection:

    1. Subjects who are anti-HBc positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B polymerase chain reaction (PCR) positive will be excluded.
    2. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCR positive will be excluded.

Additional exclusion criteria - venetoclax combination

  1. Adults with previously untreated diagnosis of AML (bone marrow blasts ≥ 20%), UNLESS they fulfil inclusion criterion 1(a) above.
  2. WBC count > 25,000 cells/mm3 (25 x 109/L); use of leukapheresis or hydroxyurea before venetoclax initiation is allowed to achieve this entry criterion (leukapheresis or hydroxyurea must be stopped at least 48 hours before the initiation of venetoclax).
  3. AML with known active central nervous system involvement.
  4. Chronic respiratory disease that requires continuous oxygen use.
  5. Previous venetoclax exposure that ended due to venetoclax toxicity.
  6. Use of moderate CYP3A inhibitor/inducers and P-gP inhibitors, with the exception of fluconazole and isavuconazole, that cannot be discontinued prior to Day 1 of dosing. Washout periods should be a minimum of 5 half-lives depending on the medication unless agreed upon with the Sponsor.
  7. Patient consumed grapefruit, grapefruit products, Seville oranges (including marmalades containing Seville oranges) or star fruit within 3 days before the initiation of venetoclax.

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): NCT03217838


Locations
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United States, Colorado
Research Site
Denver, Colorado, United States, 80218
United States, Florida
Research Site
Sarasota, Florida, United States, 34232
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
United States, Ohio
Research Site
Canton, Ohio, United States, 44718
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Dallas, Texas, United States, 75246
Research Site
Houston, Texas, United States, 77030
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53326
Australia
Research Site
Melbourne, Australia, 3004
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Johanna Bendell, MD SCRI Development Innovations, LLC
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03217838    
Other Study ID Numbers: D6130C00003
HEMREF 41 ( Other Identifier: Sarah Cannon Development Innovations, LLC )
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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 AstraZeneca:
AML
Acute Myeloid Leukaemia
AZD2811
AZD1152
AZD1152 hQPA
barasertib
azacitidine
VIDAZA®
venetoclax
VENCLEXTA®
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Venetoclax
Pyrazole
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors