A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia
NCT02954653
ABOUT THIS STUDY
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Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral blood (PB) blast counts >/= 20%) and have received prior chemotherapy and/or standard of care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing residual blast 10-14 days post-induction chemotherapy).
• Patients that are not candidates to receive standard of care and/or refusing the standard care of therapies will also be considered.
Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML population (AML with bone marrow or peripheral blast counts 20%):
- Cohort 1: Fit to receive intensive remission induction chemotherapy.
- Cohort 2: Unfit to receive or not considered a candidate for intensive remission induction chemotherapy.
Part 1 and 2:
- Life expectancy at least 12 weeks.
- Hydroxyurea is allowed on study to control total peripheral white blood cell count but must be ceased 24 hours prior to first dose.
- Off of prior therapy for 2-4 weeks prior to first dose.
- ECOG performance status: 0 to 2.
- Resolved acute effects of any prior therapy.
- Adequate renal and hepatic function.
- Patients with acute promyelocytic leukemia, AML with known central nervous system
(CNS) involvement unless the patient has completed treatment for the CNS disease, has
recovered from the acute effects of therapy prior to study entry, and is
neurologically stable.
- Patient is known refractory to platelet or packed red cell transfusions per
institutional guidelines.
- Prior treatment with a compound targeting CXCR4.
- Chronic systemic corticosteroid treatment.
- Known or suspected hypersensitivity to recombinant human proteins.
- Chronic graft versus host disease (GVHD), active GVHD with other than Grade 1 skin
involvement, or GVHD requiring systemic immunosuppressive treatment (Part 1 and cohort
3).
- Not recovered from stem cell transplant associated toxicities (Part 1 and cohort 3).
- Prior treatment with hypomethylating agents or chemotherapy for antecedent
myelodysplastic syndrome (MDS) (Part 2, cohort 2)
- AML associated with favorable risk karyotypes, including inv(16), t(8;21), t(16;16),
or t(15;17) (cohort 2)
- Candidates for allogeneic stem cell transplant (Part 2, cohort 2)
- Known hypersensitivity to cytarabine or daunorubicin (Part 2, cohort 1) and decitabine
or azacitidine or mannitol (Part 2, cohort 2).
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Descriptive Information | |||||
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Brief Title ICMJE | A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia | ||||
Official Title ICMJE | A PHASE 1 DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF INTRAVENOUS PF-06747143, ADMINISTERED AS SINGLE AGENT OR IN COMBINATION WITH STANDARD CHEMOTHERAPY IN ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA | ||||
Brief Summary | Two part, dose escalation and dose expansion study. Open label, multi center, non randomized, multiple dose, safety, pharmacokinetic and pharmacodynamic study of single agent PF-06747143 in sequential dose levels of adult patients with refractory or relapsed AML in order to establish maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) or maximally permitted dose (MPD) following by a 3 arm dose expansion with PF-06747143 in combination with standard of care chemotherapy in adult patients with AML. | ||||
Detailed Description | Patients will receive intravenous (IV) PF-06747143 as a weekly infusion (QW) in 28 day cycles at escalating doses. The proposed dosing scheme includes 0.3, 1.0, 3.0, 10, 15, and 20 mg/kg. Patients will be monitored for dose limiting toxicity (DLT) in the dose escalation in order to define the MTD. Two of the three arms in the dose expansion will include PF-06747143 in combination with standard of care chemotherapy and will include a safety lead in. The third arm, pending clinical data, will be PF-06747143 as a single agent. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Acute Myeloid Leukemia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Liu SH, Gu Y, Pascual B, Yan Z, Hallin M, Zhang C, Fan C, Wang W, Lam J, Spilker ME, Yafawi R, Blasi E, Simmons B, Huser N, Ho WH, Lindquist K, Tran TT, Kudaravalli J, Ma JT, Jimenez G, Barman I, Brown C, Chin SM, Costa MJ, Shelton D, Smeal T, Fantin VR, Pernasetti F. A novel CXCR4 antagonist IgG1 antibody (PF-06747143) for the treatment of hematologic malignancies. Blood Adv. 2017 Jun 21;1(15):1088-1100. doi: 10.1182/bloodadvances.2016003921. eCollection 2017 Jun 27. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE | 8 | ||||
Original Estimated Enrollment ICMJE | 152 | ||||
Actual Study Completion Date ICMJE | December 5, 2017 | ||||
Actual Primary Completion Date | December 5, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral blood (PB) blast counts >/= 20%) and have received prior chemotherapy and/or standard of care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing residual blast 10-14 days post-induction chemotherapy). ? Patients that are not candidates to receive standard of care and/or refusing the standard care of therapies will also be considered. Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML population (AML with bone marrow or peripheral blast counts 20%):
Part 1 and 2:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02954653 | ||||
Other Study ID Numbers ICMJE | B7861002 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | November 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |