A Phase I Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1001 (L-Grb-2 Antisense Oligonucleotide) in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Philadelphia Chromosome Positive Chronic Myelogenous Leukemia, or Acute Lymphoblastic Leukemia, and Myelodysplastic Syndrome
Sponsor study identifier
interventional
60
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 30, 2017
Actual (reported)Study Completion
March 30, 2017
Actual (reported)The first goal of this clinical research study is to find the highest safe dose of BP1001, a liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide (L-Grb2 AS), for patients with Philadelphia Chromosome positive CML, AML, ALL and MDS. The response of the leukemia to this treatment will also be studied. The second goal of this clinical research study is to evaluate the safety and toxicity of the combination of BP1001 and concurrent low-dose ara-C (LDAC) in patients with AML.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
July 7, 2010
Actual (reported)July 9, 2010
Actual (reported)March 30, 2017
Actual (reported)March 30, 2017
Actual (reported)Safety of BP1001
Evaluate toxicity, tolerance, and MTD of escalating doses of BP1001
30 days
Safety of BP1001 in combination with LDAC
Evaluate safety and toxicity of the combination of BP1001 and concurrent LDAC using non-hematologic and hematologic measures per NCI CTCAE criteria.
30 days
Optimal biologically active dose
30 days
Subjects are treated with open-label study drug (BP1001) in a dose-escalation model.
AML subjects are treated with open-label escalating study drug (BP1001) in combination with low dose ara-C (LDAC)
Study drug (BP1001) is constituted in normal saline, administered by IV on twice weekly for 28 days.
Study drug (BP1001) is constituted in normal saline, administered by IV twice weekly for 28 days. Low dose ara-C (LDAC) is self administered twice daily for 10 consecutive days during the 28 day cycle.
M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Ohanian M, Tari Ashizawa A, Garcia-Manero G, Pemmaraju N, Kadia T, Jabbour E, Ravandi F, Borthakur G, Andreeff M, Konopleva M, Lim M, Pierce S, O'Brien S, Alvarado Y, Verstovsek S, Wierda W, Kantarjian H, Cortes J. Liposomal Grb2 antisense oligodeoxynucleotide (BP1001) in patients with refractory or relapsed haematological malignancies: a single-centre, open-label, dose-escalation, phase 1/1b trial. Lancet Haematol. 2018 Apr;5(4):e136-e146. doi: 10.1016/S2352-3026(18)30021-8. Epub 2018 Mar 14.
Jorge Cortes, MD
M.D. Anderson Cancer Center
Maro Ohanian, MD
M.D. Anderson Cancer Center
First Submitted
July 7, 2010
First Posted
July 9, 2010
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 30, 2017
Actual (reported)A Pediatric Study of a Plerixafor Containing Regimen In Second Allogeneic Stem Cell Transplantation
In vivo pharmacokinetics
30 days
Correlate PK data with historical experience
30 days
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Contact the study team to confirm eligibility.
Study Completion
March 30, 2017
Actual (reported)Last Updated
May 28, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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