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Angiogenesis Inhibitor
Nab-Paclitaxel + Bevacizumab for Advanced Cancer
Phase 1
Waitlist Available
Led By Matthew S Block
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Endometrial cancer expansion cohort only: Histologic proof of endometrial cancer including endometrioid, serous, clear cell, mucinous, undifferentiated, mixed, and carcinosarcoma histologies
At least one prior line of cytotoxic chemotherapy must also have contained bevacizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of the combination of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma or other cancers of the cervix, endometrium, ovary, fallopian tube, or peritoneal cavity.
Who is the study for?
This trial is for adults with stage IV melanoma or gynecological cancers that can't be surgically removed. Participants must have had 1-4 prior chemotherapy treatments, including a taxane and platinum agent, and be resistant to platinum if they've had 1-2 chemo lines. They should not have received certain therapies recently and must not have other severe diseases or conditions that could affect the study.Check my eligibility
What is being tested?
The trial tests nab-paclitaxel combined with bevacizumab versus nab-paclitaxel alone in patients with advanced melanoma or gynecological cancers. It aims to find the safest doses and see if adding bevacizumab improves outcomes by inhibiting blood vessel growth necessary for tumor survival.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, low blood cell counts increasing infection risk, nerve damage causing numbness or tingling sensations (neuropathy), high blood pressure due to bevacizumab's effect on blood vessels, and increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer has been confirmed by tissue analysis.
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I have received chemotherapy that included bevacizumab.
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I have had at least one treatment for cancer that has spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My nerve damage symptoms are mild or not present.
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I have stage IV melanoma that cannot be removed with surgery.
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My cancer is a type of endometrial cancer.
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I have ovarian cancer and received specific drugs in my treatment.
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I do not have any nerve damage in my hands or feet.
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I've had 1-3 rounds of specific cancer treatments, not including hormone therapy.
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My first cancer treatment included a taxane, platinum drug, and immune checkpoint inhibitor.
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I've had 2-3 treatments including a taxane, a platinum drug, and an immune therapy.
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I have previously received chemotherapy that included both a taxane and a platinum agent.
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My cancer did not respond to platinum-based chemotherapy after 1 or 2 treatments.
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I have had 1-4 rounds of chemotherapy.
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My cancer is a type of gynecologic cancer.
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I am 18 years old or older.
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My melanoma can be measured by scans and is at least 1 cm large.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Incidence of adverse events (soft tissue expansion cohort)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreSide effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT0301035865%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AB-complex)Experimental Treatment4 Interventions
Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,711 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,080 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Matthew S BlockPrincipal InvestigatorMayo Clinic in Rochester
4 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 months.You are okay with giving blood samples for research purposes.I am currently being treated for inflammatory bowel disease.I have not had diverticulitis or pancreatitis in the last 6 months.You have had brain metastases shown on an MRI or CT scan before.My cancer returned or worsened within 6 months after my last platinum-based chemotherapy.I have had at least one treatment for cancer that has spread.Your platelet count is at least 100,000 per cubic millimeter.I am fully active or restricted in physically strenuous activity but can do light work.My nerve damage symptoms are mild or not present.I haven't had IV cancer treatment or experimental drugs in the last 4 weeks.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I understand the study drug's effects on unborn babies are unknown.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 3 years.I have a condition that increases my risk for blood clots, such as a history of clots, heart rhythm problems, severe obesity, or need for long-term blood thinners.I had severe bowel side effects from immune therapy within the last 3 months.I have not had major surgery in the last 6 weeks and do not plan to have any during the study.I have stage IV melanoma that cannot be removed with surgery.Women who can have children must have a negative pregnancy test within the past week before joining the study.My ovarian cancer is confirmed by a biopsy.I have a specific type of cancer in my cervix, endometrium, ovary, fallopian tube, or peritoneum.I've had 1-3 rounds of specific cancer treatments, not including hormone therapy.My endometrial cancer has been confirmed by tissue analysis.I have received chemotherapy that included bevacizumab.I have a tumor that can be measured by scans, or I have specific ovarian cancer markers.My hemoglobin level is at least 9.0 g/dL.My cancer did not respond to platinum-based chemotherapy after 1 or 2 treatments.My cancer is a type of endometrial cancer.I received ipilimumab treatment for melanoma less than 6 months ago.I do not have any nerve damage in my hands or feet.I can visit the hospital for a check-up 2-4 weeks after stopping treatment.I have previously received chemotherapy that included both a taxane and a platinum agent.I have ovarian cancer and received specific drugs in my treatment.My condition might improve with known treatments, except in platinum-resistant ovarian cancer where I can still join despite available treatments.I have had 3 or fewer cancer treatments in the last 2 years.My first cancer treatment included a taxane, platinum drug, and immune checkpoint inhibitor.I've had 2-3 treatments including a taxane, a platinum drug, and an immune therapy.My cancer may or may not respond to platinum-based chemotherapy after 3-4 treatments.I have had 1-4 rounds of chemotherapy.Your white blood cell count is at least 1500 per cubic millimeter.I have ovarian, fallopian tube, or peritoneal cancer and meet specific criteria.My cancer is a type of gynecologic cancer.Your alkaline phosphatase level needs to be within a certain range when tested within 14 days before joining the study.Your bilirubin levels must be within a certain range, which will be tested within two weeks before joining the study.Your liver enzyme levels are not higher than 2.5 times the normal limit.You had an allergic reaction to carboplatin or cisplatin before.You should not have protein in your urine when tested within 14 days before the study.I am 18 years old or older.I haven't taken any angiogenesis inhibitors in the last 28 days.My melanoma can be measured by scans and is at least 1 cm large.I still have side effects from my last chemotherapy that haven't gone away.My gynecologic cancer returned or worsened within 30 days after my last paclitaxel treatment.Your kidney function test result should be within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AB-complex)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Cutaneous Melanoma Patient Testimony for trial: Trial Name: NCT02020707 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other empirical research has been performed relating to Pharmacological Study?
"The pharmacological study first emerged in 1997 at City of Hope Comprehensive Cancer Center and has since seen 2650 completed trials. At the moment, 1150 active clinical studies are taking place, prominently within Jacksonville, Florida."
Answered by AI
How is Pharmacological Study typically employed to benefit patients?
"Pharmacological Study is frequently employed to treat recurrent cervical cancer, but it can also be used to control metastatic bladder cancer, mediastinitis, and locally advanced non-small cell lung cancer."
Answered by AI
What is the enrolment count for this trial?
"Affirmative. The clinicaltrials.gov website confirms that this research has been available since February 3rd 2014 and is actively recruiting participants--requiring 73 people from 6 different medical sites."
Answered by AI
Are there any Canadian locations conducting this experiment?
"This clinical trial is presently taking on patients at 6 sites, including Jacksonville, Phoenix and Rochester. To reduce the burden of travel associated with enrolment, we recommend choosing a location close to you."
Answered by AI
Is there still opportunity for enrollment in this clinical trial?
"Yes, according to the records found on clinicaltrials.gov this trial is actively recruiting participants. Initially posted on February 3rd 2014 and most recently refreshed on April 11th 2022, 73 patients are sought at 6 different sites."
Answered by AI
Has the Pharmacological Study been validated by federal regulators?
"Our evaluation team has assessed that this Phase 1 clinical trial has a safety rating of 1 due to the lack of evidence in regards to both effectiveness and potential adverse reactions."
Answered by AI
Who else is applying?
What state do they live in?
Utah
What site did they apply to?
Mayo Clinic Hospital in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I'm s/p hysterectomy, carbo/taxol (9-12/21) - 4 months s/p therapy completion found with metastatic, serous, adenocarcinoma. Failed followup therapy with 2 immune checkpoint inhibitors (PD-1 and TIGIT) (10/22). Currently in, and likely failing therapy with Seagen's antibody drug conjugate (SGNB7H4V-001) - repeat CT not performed yet but Ca-125 increased from 265 to 380.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Mayo Clinic Hospital in Arizona: < 48 hours
Average response time
- < 2 Days
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