Chronic Myelogenous Leukemia, Ph1-PositivePhase 1/2NCT02923986
Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS
A Phase 1/2 study testing BP1001 (varying dose), BP1001 (fixed dose) and Dasatinib in people with Chronic Myelogenous Leukemia, Ph1-Positive and Acute Myeloid Leukemia, run by Bio-Path Holdings, Inc. at 1 site in United States.
Trial summary
The primary objective of the Phase Ib study is to determine the dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of BP1001 in combination with dasatinib in patients with with Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) including chronic phase patients who have failed initial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- BP1001 (varying dose), BP1001 (fixed dose) and Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 27 May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:
- Adults ≥18 years of age
- Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or dasatinib
- Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or dasatinib
- Histologically documented diagnosis of Ph+ CML including chronic phase patients who have failed initial TKI therapy, accelerated or blast phase, Ph+ AML or High-risk Ph+ MDS.
- Ph+ chronic phase CML patients who are resistant to 1 or more TKIs, including dasatinib. Dasatinib-resistant patients can enroll in the Phase Ib portion of the study but are excluded from the Phase IIa portion of the study.
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- One of the following parameters is required to meet criteria for accelerated CML:
- Blasts in Peripheral Blood or Bone Marrow ≥15%
- Promyelocytes and Blasts in Peripheral Blood or Bone Marrow ≥30%
- PB or BM basophils ≥20%
- Thrombocytopenia <100 x 103/ml, not resulting from therapy
- Cytogenetic clonal evolution CML blast phase is defined as ≥30% blasts in peripheral blood or bone marrow, or presence of extramedullary disease, except for liver or spleen.
- AML/MDS
- Ph+ AML is defined as:
- Ph+ and meets diagnostic criteria for AML
- o Myeloid blasts ≥20 % or presence of AML-defining recurrent cytogenetic abnormality.
- Ph+ high-risk MDS defined as:
- Ph+ high risk MDS ≥10% myeloid blasts or IPSS ≥intermediate-2
- Adequate hepatic and renal functions as defined by:
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
- Total bilirubin ≤1.5 times ULN; and
- Estimated glomerular filtration rate (eGFR) of at least 40 ml/min. These estimations can be calculated using any of the following methods (Appendix D):
- Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
- GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] ii. Cockcroft gault equation
- Cockcroft Gault equation utilizing the TBW (Total body weight) to calculate an estimated creatinine clearance iii. CrCl = [(140 - age) x TBW] / (Scr x 72) x 0.85 [if female]
- Modification of Diet in Renal Disease (MDRD) Study equation iv. GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × 0.74 [if female] x 1.212 [if African American (AA)]
- Creatinine clearance estimated by 24-hr urine collection for creatinine clearance
- Documented Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
- Willing and able to provide written informed consent
Who cannot join
- At the time of Screening, participants who meet any of the following criteria will be excluded from participating in the study:
- Patients with T315I mutation will not be excluded, but their response will be analyzed separately.
- Another primary malignancy other than CML, AML, or MDS within the past 2 years except non-melanoma skin cancer, or carcinoma in situ of the cervix.
- Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based on at least 2 consecutive documented, negative spinal fluid assessment prior to Screening
- Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (i.e., ≥20% blasts in bone marrow aspirate)
- Receipt of any anti-cancer therapy within 14 days of starting BP1001, with the exception of hydroxyurea or anagrelide, or TKI (within 2 days)
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- Uncontrolled active, untreated, or progressive infection
- Receipt of any investigational agent within 14 days or 5 half-lives of starting BP1001
- Females who are pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days after last dose of study drug
- Prior exposure to BP1001
- Patients with a history of intolerance to dasatinib or for whom dasatinib may not be appropriate
- Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study
- Known active or clinically significant hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitis C infection (based on positive antibody [HCV Ab]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)
- Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality (e.g., QTcF >470 msec)
- Has had any of the following: clinically significant pleural effusion within 2 months, myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack within 6 months.
- Uncontrolled seizure disorder (i.e., seizures within the past 2 months).
- Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase Ib/IIa Single-arm, Open-label Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) Including Chronic Phase Patients Who Have Failed Initial Tyrosine Kinase Inhibitor (TKI) Therapy, Accelerated or Blast Phase, Ph+ Acute Myeloid Leukemia (AML) or High-risk Ph+ Myelodysplastic Syndrome (MDS)
The primary objective of the Phase Ib study is to determine the dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of BP1001 in combination with dasatinib in patients with with Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) including chronic phase patients who have failed initial tyrosine kinase inhibitor (TKI) therapy, accelerated or blast phase, Ph+ Acute Myeloid Leukemia (AML) or High-risk Ph+ Myelodysplastic Syndrome (MDS). The primary objective of the Phase IIa study is to assess the efficacy of the combination of BP1001 and dasatinib in patients with Ph+ CML, Ph+AML, or high-risk Ph+ MDS.
Read the detailed description
The Grb2 gene has been mapped to the human chromosome region 17q22-qter, a region that is duplicated in leukemias and solid tumors, which may result in an increased copy number of the Grb2 gene product. As Grb2 is important for the transformation of murine hematopoietic cells, and the proliferation of human leukemia cells that express high levels of oncogenic tyrosine kinases, inhibition of Grb2 may have a significant impact on the natural history of leukemias. The study drug (BP1001) may be able to inhibit the cells from making Grb-2. Researchers hope that without this protein, the leukemia cells will die.
Researchers hope that the combination of BP1001 and Das will provide a benefit to Ph+ CML patients, including chronic phase patients who have failed initial TKI therapy, accelerated or blast phase Ph+ AML, and high-risk Ph+ MDS patients.
This is a Phase Ib/IIa, multicenter, study of BP1001 in combination with Das in participants with Ph+ CML, including chronic phase patients who have failed initial TKI therapy, accelerated or blast phase Ph+ AML, and high-risk Ph+ MDS.
This is a Phase Ib/IIa, multicenter, study of BP1001 in combination with dasatinib in participants with Ph+ CML who are in chronic phase who have failed initial TKI therapy, accelerated or blast phase, Ph+ AML or high-risk Ph+ MDS.
This trial will utilize a single arm, open label design to assess the safety profile, DLT, MTD, PK, and efficacy of BP1001 in combination with dasatinib.
The Phase Ib study employs an open-label, sequential, dose-escalation design to assess safety, tolerability and toxicity, tumor response and anti-leukemic activity.
A standard "3+3" design will be used in which successive cohorts of patients are being treated with BP1001 at the MTD (or highest tested dose [HTD] if the MTD is not defined) and 1 level below the MTD (or HTD) in combination with a fixed dose of dasatinib to characterize safety and biological effect, as well as identify the recommended Phase IIa dose.
Up to 6 evaluable participants are expected to participate in the Phase Ib part of the study and up to 40 evaluable participants are expected to participate in the Phase IIa part of the study.
- Conditions
- Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- BP1001 (varying dose), BP1001 (fixed dose), Dasatinib
- Keywords
- Liposomal Grb-2 treatment of Ph+ CML, Liposomal Grb-2 with Das for Ph+ CML, Liposomal Grb-2 treatment of Ph+ AML, Liposomal Grb-2 with Das for Ph+ AML, Liposomal Grb-2 treatment of Ph+ MDS, Liposomal Grb-2 with Das for Ph+ MDS
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1001 (varying dose)Drug
Also called Liposomal Grb-2, L-Grb-2
BP1001 (varying dose)
BP1001 (fixed dose)Drug
Also called Liposomal Grb-2, L-Grb-2
BP1001 (fixed dose)
DasatinibDrug
Also called Das
Dasatinib
| Study group | Role | What they receive |
|---|---|---|
| BP1001 (varying dose) + Dasatinib | Experimental | Phase 1b: BP1001 (varying dose levels) in combination with Das Receives: Drug: BP1001 (varying dose); Drug: Dasatinib |
| BP1001 (fixed dose) + Dasatinib | Experimental | Phase IIa: BP1001 (fixed dose based on Phase 1b) in combination with Das Receives: Drug: BP1001 (fixed dose); Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria
Phase 1b portion of the study: Determine the dose limiting toxicity of BP1001 in combination with Das
Measured: 240 days
Maximum Tolerated Dose of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria
Phase 1b portion of the study: Determine the maximum tolerated dose of BP1001 in combination with Das
Measured: 240 days
Efficacy of the combination of BP1001 and Das using hematologic response by bone marrow aspirate or biopsy and complete blood counts
Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das
Measured: 240 days
Efficacy of the combination of BP1001 and Das using cytogenetic response (karyotyping) by bone marrow aspirate or biopsy
Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das
Measured: 240 days
Efficacy of the combination of BP1001 and Das using molecular response (PCR) by bone marrow aspirate or biopsy
Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das
Measured: 240 days
Secondary outcomes (12)
Safety of BP1001 in combination with Das using non-hematologic and hematologic parameters per NCI CTCAE criteria
Evaluate Safety of BP1001 in combination with Das
Measured: 30 days
Efficacy of the combination of BP1001 and Das using hematologic response by bone marrow aspirate or biopsy and complete blood counts versus Das alone by historical outcome comparison
Determine whether the combination of BP1001 and Das provides greater efficacy (Hematologic Response) than Das alone (by historical comparison)
Measured: 240 days
Efficacy of the combination of BP1001 and Das using cytogenetic response (karyotyping) by bone marrow aspirate or biopsy versus Das alone by historical outcome comparison
Determine whether the combination of BP1001 and Das provides greater efficacy (Cytogenetic Response) than Das alone (by historical comparison)
Measured: 240 days
Efficacy of the combination of BP1001 and Das using molecular response (PCR) by bone marrow aspirate or biopsy versus Das alone by historical outcome comparison
Determine whether the combination of BP1001 and Das provides greater efficacy (Molecular Response) than Das alone (by historical comparison)
Measured: 240 days
In vivo PK using plasma to compute half life and elimination
Evaluate in vivo PK of BP1001 when given alone and in combination with Das
Measured: 30 days
Time to Response using hematologic response using bone marrow biopsy or aspirate and complete blood counts
Assess time to response from administration of BP1001 + Das to hematologic response
Measured: 30 days
Time to Response using cytogenetic response (karyotyping) using bone marrow biopsy or aspirate
Assess time to response from administration of BP1001 + Das to cytogenetic response
Measured: 30 days
Time to Response using molecular response (PCR) using bone marrow biopsy or aspirate
Assess time to response from administration of BP1001 + Das to molecular response
Measured: 30 days
Duration of Response using hematologic response using bone marrow biopsy or aspirate and complete blood counts from day of response to day of disease progression
Assess duration of response from day of response to day of disease progression
Measured: 30 days
Duration of Response using cytogenetic response (karyotyping) using bone marrow biopsy or aspirate from day of response to day of disease progression
Assess duration of response from day of response to day of disease progression
Measured: 30 days
Duration of Response using molecular response (PCR) using bone marrow biopsy or aspirate from day of response to day of disease progression
Assess duration of response from day of response to day of disease progression
Measured: 30 days
Overall Survival from date of study entry to study closure
Assess overall survival from date of study entry to study closure
Measured: 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Sep 2017
- Primary completion27 May 2020
- Study completion27 May 2020
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous Leukemia, Ph1-PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Path Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maro Ohanian, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923986
- Sponsor's protocol ID
- BP1001-202-CML
- Status last verified
- May 2020
- First submitted
- 12 Sep 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa Single-arm, Open-label Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) Including Chronic Phase Patients Who Have Failed Initial Tyrosine Kinase Inhibitor (TKI) Therapy, Accelerated or Blast Phase, Ph+ Acute Myeloid Leukemia (AML) or High-risk Ph+ Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT02923986
- Acronym / sponsor ID
- BP1001-202-CML
- Conditions
- Chronic Myelogenous Leukemia, Ph1-Positive, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Keywords
- Liposomal Grb-2 treatment of Ph+ CML, Liposomal Grb-2 with Das for Ph+ CML, Liposomal Grb-2 treatment of Ph+ AML, Liposomal Grb-2 with Das for Ph+ AML, Liposomal Grb-2 treatment of Ph+ MDS, Liposomal Grb-2 with Das for Ph+ MDS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bio-Path Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the Phase Ib study is to determine the dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of BP1001 in combination with dasatinib in patients with with Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) including chronic phase patients who have failed initial tyrosine kinase inhibitor (TKI) therapy, accelerated or blast phase, Ph+ Acute Myeloid Leukemia (AML) or High-risk Ph+ Myelodysplastic Syndrome (MDS). The primary objective of the Phase IIa study is to assess the efficacy of the combination of BP1001 and dasatinib in patients with Ph+ CML, Ph+AML, or high-risk Ph+ MDS.
Detailed description
The Grb2 gene has been mapped to the human chromosome region 17q22-qter, a region that is duplicated in leukemias and solid tumors, which may result in an increased copy number of the Grb2 gene product. As Grb2 is important for the transformation of murine hematopoietic cells, and the proliferation of human leukemia cells that express high levels of oncogenic tyrosine kinases, inhibition of Grb2 may have a significant impact on the natural history of leukemias. The study drug (BP1001) may be able to inhibit the cells from making Grb-2. Researchers hope that without this protein, the leukemia cells will die.
Researchers hope that the combination of BP1001 and Das will provide a benefit to Ph+ CML patients, including chronic phase patients who have failed initial TKI therapy, accelerated or blast phase Ph+ AML, and high-risk Ph+ MDS patients.
This is a Phase Ib/IIa, multicenter, study of BP1001 in combination with Das in participants with Ph+ CML, including chronic phase patients who have failed initial TKI therapy, accelerated or blast phase Ph+ AML, and high-risk Ph+ MDS.
This is a Phase Ib/IIa, multicenter, study of BP1001 in combination with dasatinib in participants with Ph+ CML who are in chronic phase who have failed initial TKI therapy, accelerated or blast phase, Ph+ AML or high-risk Ph+ MDS.
This trial will utilize a single arm, open label design to assess the safety profile, DLT, MTD, PK, and efficacy of BP1001 in combination with dasatinib.
The Phase Ib study employs an open-label, sequential, dose-escalation design to assess safety, tolerability and toxicity, tumor response and anti-leukemic activity.
A standard "3+3" design will be used in which successive cohorts of patients are being treated with BP1001 at the MTD (or highest tested dose [HTD] if the MTD is not defined) and 1 level below the MTD (or HTD) in combination with a fixed dose of dasatinib to characterize safety and biological effect, as well as identify the recommended Phase IIa dose.
Up to 6 evaluable participants are expected to participate in the Phase Ib part of the study and up to 40 evaluable participants are expected to participate in the Phase IIa part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP1001 (varying dose) + Dasatinib | Experimental | Drug: BP1001 (varying dose), Drug: DasatinibPhase 1b: BP1001 (varying dose levels) in combination with Das |
| BP1001 (fixed dose) + Dasatinib | Experimental | Drug: BP1001 (fixed dose), Drug: DasatinibPhase IIa: BP1001 (fixed dose based on Phase 1b) in combination with Das |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:
- Adults ≥18 years of age
- Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or dasatinib
- Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or dasatinib
- Histologically documented diagnosis of Ph+ CML including chronic phase patients who have failed initial TKI therapy, accelerated or blast phase, Ph+ AML or High-risk Ph+ MDS.
Key exclusion criteria (17 listed)
- At the time of Screening, participants who meet any of the following criteria will be excluded from participating in the study:
- Patients with T315I mutation will not be excluded, but their response will be analyzed separately.
- Another primary malignancy other than CML, AML, or MDS within the past 2 years except non-melanoma skin cancer, or carcinoma in situ of the cervix.
- Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based on at least 2 consecutive documented, negative spinal fluid assessment prior to Screening
- Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (i.e., ≥20% blasts in bone marrow aspirate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP1001 (varying dose)Also: Liposomal Grb-2, L-Grb-2BP1001 (varying dose) | Drug | BP1001 (varying dose) + Dasatinib |
| BP1001 (fixed dose)Also: Liposomal Grb-2, L-Grb-2BP1001 (fixed dose) | Drug | BP1001 (fixed dose) + Dasatinib |
| DasatinibAlso: DasDasatinib | Drug | BP1001 (fixed dose) + Dasatinib, BP1001 (varying dose) + Dasatinib |
Primary outcome
Dose Limiting Toxicity of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria
Time frame: 240 days
Phase 1b portion of the study: Determine the dose limiting toxicity of BP1001 in combination with Das
Maximum Tolerated Dose of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria
Time frame: 240 days
Phase 1b portion of the study: Determine the maximum tolerated dose of BP1001 in combination with Das
Efficacy of the combination of BP1001 and Das using hematologic response by bone marrow aspirate or biopsy and complete blood counts
Time frame: 240 days
Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das
Efficacy of the combination of BP1001 and Das using cytogenetic response (karyotyping) by bone marrow aspirate or biopsy
Time frame: 240 days
Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das
Efficacy of the combination of BP1001 and Das using molecular response (PCR) by bone marrow aspirate or biopsy
Time frame: 240 days
Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das
12 secondary outcomes
Safety of BP1001 in combination with Das using non-hematologic and hematologic parameters per NCI CTCAE criteria
Time frame: 30 days
Efficacy of the combination of BP1001 and Das using hematologic response by bone marrow aspirate or biopsy and complete blood counts versus Das alone by historical outcome comparison
Time frame: 240 days
Efficacy of the combination of BP1001 and Das using cytogenetic response (karyotyping) by bone marrow aspirate or biopsy versus Das alone by historical outcome comparison
Time frame: 240 days
Efficacy of the combination of BP1001 and Das using molecular response (PCR) by bone marrow aspirate or biopsy versus Das alone by historical outcome comparison
Time frame: 240 days
In vivo PK using plasma to compute half life and elimination
Time frame: 30 days
Time to Response using hematologic response using bone marrow biopsy or aspirate and complete blood counts
Time frame: 30 days
Time to Response using cytogenetic response (karyotyping) using bone marrow biopsy or aspirate
Time frame: 30 days
Time to Response using molecular response (PCR) using bone marrow biopsy or aspirate
Time frame: 30 days
Duration of Response using hematologic response using bone marrow biopsy or aspirate and complete blood counts from day of response to day of disease progression
Time frame: 30 days
Duration of Response using cytogenetic response (karyotyping) using bone marrow biopsy or aspirate from day of response to day of disease progression
Time frame: 30 days
Duration of Response using molecular response (PCR) using bone marrow biopsy or aspirate from day of response to day of disease progression
Time frame: 30 days
Overall Survival from date of study entry to study closure
Time frame: 240 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maro Ohanian, M.D. principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BP1001 (varying dose), BP1001 (fixed dose) and Dasatinib in people with Chronic Myelogenous Leukemia, Ph1-Positive and Acute Myeloid Leukemia, run by Bio-Path Holdings, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria (time frame: 240 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.