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BP1001-A + Paclitaxel for Solid Tumors
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective. The first part will see how much of the drug people can tolerate, and the second part will test the drug in combination with another cancer drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had a severe allergic reaction to paclitaxel or docetaxel in the past.I have no lasting side effects worse than mild from previous treatments.I have HIV with a specific CD4+ T-cell count or active hepatitis B/C.I have not had major surgery, dental surgery, or biopsy recently.I am willing to have biopsies before and, if needed, after treatment.My cancer can be measured and has a specific area that can be evaluated.You cannot have an MRI scan or have had an allergic reaction to gadolinium contrast agents in the past.I have not taken any strong medication that affects liver enzymes in the last two weeks.My ovarian cancer is of a specific cell type.I have no history of brain-related health issues in the past 6 months.I am 18 or older with advanced cancer and no known beneficial treatment options.My blood, liver, kidneys, nerves, and clotting functions are all working well.I have been treated with paclitaxel before under certain conditions.I agree to use contraception during the study.I have been treated with docetaxel before.I do not have any infections needing antibiotics, except for a simple UTI.I am fully active or can carry out light work.I have a specific type of ovarian, peritoneal, fallopian tube, or endometrial cancer and can be treated with paclitaxel alone.I stopped any hormone treatments for my cancer two weeks before starting this trial.I stopped all cancer treatments, including immunotherapy, at least 4 weeks ago.I am a woman who can have children, not pregnant, and agree to use birth control.I have had a bone marrow or stem cell transplant.I have fluid buildup in my chest that causes symptoms.I am not pregnant or breastfeeding.I cannot or should not receive paclitaxel for my condition.My endometrial cancer is of a specific cell type.My ovarian cancer is not low grade serous or mucinous type.I have not had a heart attack or severe heart issues in the last 6 months.
- Group 1: BP1001-A monotherapy
- Group 2: BP1001-A and Paclitaxel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What has been the efficacy of BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) in combination with paclitaxel according to prior clinical investigations?
"At the moment, 832 trials are being conducted to understand how BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel works. Of these studies, 227 have reached phase 3. While most of them are in Adelaide South Australia, there is a total of 45681 research sites across the globe testing this treatment."
How detrimental is the combination of paclitaxel and BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) for human health?
"Our internal assessment of BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) in combination with paclitaxel's safety is 1, as there is only initial evidence demonstrating the drug combo's efficacy and security."
Are participants currently being sought for this investigation?
"Affirmative, the clinicaltrials.gov entry indicates that enrollment is in progress for this medical trial. It was first published on August 19th 2022 and most recently edited on October 27th of the same year. This research effort seeks to involve 50 patients across 2 sites."
For what medical purpose is BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel typically prescribed?
"BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) in tandem with paclitaxel is frequently administered to inhibit the metastasis of neoplasms. It can also be prescribed for other ailments such as kaposi sarcoma, advanced directives, and cancers of the fallopian tubes."
What goals is this experiment seeking to accomplish?
"Bio-Path Holdings, Inc., the sponsor of this clinical trial, has reported that its primary outcome will be evaluated over 30 days and is to ascertain the Maximum Tolerable Dose (MTD) of BP1001-A. Additionally, secondary outcomes such as Overall Response duration (from biopsy data), Stable Disease period based on imaging scans, and Objective Response duration from MRI/CT images are also being monitored."
How many participants have been recruited for this experiment?
"Affirmative. Clinicaltrials.gov indicates that, since August 19th 2022, the research study has been actively seeking participants across two sites with a target of 50 patients."
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