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A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT03106428
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

March 29, 2017
April 10, 2017
October 19, 2018
March 29, 2017
July 20, 2021   (Final data collection date for primary outcome measure)
  • Occurrence of adverse events (AEs) [ Time Frame: From time of informed consent through 90 days post end of treatment ]
    To assess by the occurrence of adverse events (AEs)
  • Occurrence of serious adverse events (SAEs) [ Time Frame: From time of informed consent through 90 days post end of treatment ]
    To assess by the occurrence of serious adverse events (SAEs)
  • Occurrence of dose-limiting toxicities (DLTs) [ Time Frame: During the evaluation period of 21 or 42 days post-first dose ]
    To assess by the occurrence of non-Hematologic and hematologic toxicities, AEs, and abnormal laboratory results.
  • Number of patients with changes in laboratory parameters from baseline [ Time Frame: From time of informed consent and up to 21 days post end of treatment ]
    To assess serum chemistry, hematology, Coagulation and urinalysis
  • Number of patients with changes in vital signs from baseline [ Time Frame: From time of informed consent and up to 21 days post end of treatment ]
    To assess body temperature, blood pressure, and heart rate
  • Number of patients with changes in electrocardiogram (ECG) results from baseline [ Time Frame: From time of informed consent and up to 21 days post end of treatment ]
    To assess using twelve-lead ECG recordings
  • Percentage of patients with changes in laboratory parameters from baseline [ Time Frame: From time of informed consent and up to 21 days post end of treatment ]
    To assess serum chemistry, hematology, Coagulation and urinalysis
Same as current
Complete list of historical versions of study NCT03106428 on ClinicalTrials.gov Archive Site
  • MEDI7247 maximum observed concentration for PK [ Time Frame: From time of informed consent through 30 days post end of treatment ]
    To assess the Pharmacokinetics of MEDI7247
  • MEDI7247 area under the concentration-time curve for PK [ Time Frame: From time of informed consent through 30 days post end of treatment ]
    To assess the Pharmacokinetics of MEDI7247
  • MEDI7247 clearance for PK [ Time Frame: From time of informed consent through 30 days post end of treatment ]
    To assess the Pharmacokinetics of MEDI7247
  • MEDI7247 terminal half-life for PK [ Time Frame: From time of informed consent through 30 days post end of treatment ]
    To assess the Pharmacokinetics of MEDI7247
  • Number of subjects who develop anti-drug antibodies (ADAs) [ Time Frame: From time of informed consent through 30 days post end of treatment ]
    To assess the immunogenicity of MEDI7247
  • Best overall response (BOR) [ Time Frame: From time of informed consent and up to 3 years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI7247
  • Objective response rate (ORR) [ Time Frame: From time of informed consent and up to 3 years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI7247
  • Time to response (TTR) [ Time Frame: From time of informed consent and up to 3 years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI7247
  • Duration of response (DoR) [ Time Frame: From time of informed consent and up to 3 years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI7247
  • Progression-free survival (PFS) [ Time Frame: From time of informed consent and up to 3 years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI7247
  • Overall survival (OS) [ Time Frame: From time of informed consent and up to 3 years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI7247
Same as current
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Multiple Myeloma
  • Diffuse Large B-cell Lymphoma
Drug: MEDI7247
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV Q3W
  • Experimental: acute myeloid leukemia
    Patients with R/R AML by World Health Organization (WHO) classification (Arber et al, 2016) who have failed prior standard therapy and for whom no standard therapies are available
    Intervention: Drug: MEDI7247
  • Experimental: Multiple Myeloma
    Patients with R/R MM who have failed prior standard therapy(ies) which should include immunomodulatory agents and proteasome inhibitors and for whom there is no standard salvage regimen.
    Intervention: Drug: MEDI7247
  • Experimental: Diffuse Large B-cell Lymphoma
    Patients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen.
    Intervention: Drug: MEDI7247
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
228
Same as current
July 20, 2021
July 20, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
  2. Age ≥ 18 years at the time of screening.
  3. Written informed consent and any locally required authorization
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 during dose finding, 0-2 during MTD expansion
  5. CrCL ≥ 40 mL/min
  6. Female patients of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from 7 days post-screening, and must agree to continue using such precautions for 90 days after the last dose of investigational product.
  7. Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product.

Exclusion Criteria:

  1. Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
  2. Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy within 28 days of the first scheduled dose of MEDI7247.
  3. Received an investigational drug within 14 days or 5 half-lives, whichever is shorter, of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
  4. Patients who have previously received an autologous SCT, are excluded if less than 90 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of MEDI7247.
  5. Failure to recover from all prior treatment-related non-hematological toxicities to ≤ Grade 1 prior to the first scheduled dose of MEDI7247 (except for alopecia and neuropathy).
  6. Patients at risk of non-disease related major bleeding (eg, recent GI hemorrhage or neurosurgery, within previous 21 days).
  7. Current severe active systemic disease including active concurrent malignancy
  8. Central nervous system (CNS) disease that is untreated, symptomatic, or requires therapy to control symptoms.
  9. Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Canada,   France,   Korea, Republic of,   United States
 
 
NCT03106428
D8540C00001
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
MedImmune LLC
MedImmune LLC
Not Provided
Not Provided
MedImmune LLC
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP