Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients Wit… (NCT02495896) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
United States61 participantsStarted 2015-09-03
Plain-language summary
This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein when given together with standard chemotherapy regimens in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic). Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein, paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, docetaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether standard chemotherapy regimens are more effective with recombinant ephB4-HSA fusion protein in treating advanced or metastatic solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Patients must have a life expectancy of at least 12 weeks
* Patients must be able to comprehend and provide written informed consent
* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:
* Amenorrhea \>= 12 consecutive months without another cause or
* For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL
* Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be conside…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of overall response or SD
Timeframe: From first occurrence of CR, PR or SD to the time of documented disease progression, as determined by investigator review of tumor assessments using RECIST v1.1, or death from any cause, assessed up to 2 years
2
Incidence of toxicities, graded according to Common Terminology Criteria for Adverse Events version 4
Timeframe: Up to 2 years
3
Objective response using RECIST version 1.1
Timeframe: Up to 2 years
4
Overall survival
Timeframe: Time from start of treatment with recombinant EphB4-HSA fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years
5
Progression-free survival
Timeframe: Time from start of treatment to 1st documentation of PD or death due to any cause, or death from any cause, assessed up to 2 years