RecruitingPhase 2NCT02781883

Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy


Sponsor

Bio-Path Holdings, Inc.

Enrollment

108 participants

Start Date

May 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new three-drug combination — BP1001 (an experimental drug), venetoclax (a targeted drug that causes cancer cells to self-destruct), and decitabine (a chemotherapy that reprograms cancer cells) — for people with acute myeloid leukemia (AML), a fast-growing blood cancer. **You may be eligible if...** - You are 18 years or older - You have newly diagnosed AML, secondary AML (arising from a prior blood disorder), or AML that has returned or is not responding to treatment - Your heart, liver, kidneys, and blood counts meet minimum function requirements - Women must be post-menopausal, surgically sterile, or use reliable contraception during and for 30 days after treatment - Men must use contraception during and for at least 30 days after treatment **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems - You have an active infection - You have recently been treated with venetoclax or decitabine without response - You have other serious medical conditions making participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBP1001 in combination with Ventoclax plus decitabine

BP1001 in combination with Ventoclax plus decitabine

DRUGBP1001 plus decitabine

BP1001 plus decitabine in ventoclax intolerant or resistant subjects


Locations(9)

UCLA Medical Center

Los Angeles, California, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

University of Kansas Cancer Center

Fairway, Kansas, United States

New Jersey Hematology Oncology Associates

Brick, New Jersey, United States

Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health

New York, New York, United States

Weill Cornell Medical College - New York - Presbyterian Hospital

New York, New York, United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Baylor Scott & White Research Institute

Temple, Texas, United States

West Virginia University/Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT02781883


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