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Study Summary
This trial is testing a new drug called XL102 to see if it is safe and effective against solid tumors.
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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- I do not have an active infection or HIV/AIDS, and I am not currently being treated for hepatitis B or C or tuberculosis.You have severe heart problems, uncontrolled high blood pressure, or have had a stroke, heart attack, or other serious heart or blood vessel problems within the last 6 months. If you had a blood clot in your leg, it's okay as long as it has been treated and you are feeling okay.I haven't taken any targeted cancer drugs in the last 2 weeks.I do not have any severe illnesses that are not under control.I haven't had any cancer besides skin cancer or low-grade tumors in the past 2 years.My breast cancer is hormone receptor-positive and HER-2 negative, and it has worsened despite treatment.I have recovered from COVID-19 at least 10 days ago or have a negative PCR test.My liver function is significantly impaired.I require dialysis treatment.I haven't had chemotherapy or antibody therapy in the last 21 days.I can eat a high-fat meal without issues and have no allergies to its components.I am taking other medications.My brain tumor or metastases have been treated and stable for at least 4 weeks.My cancer is confirmed, cannot be removed by surgery, and has spread or come back.I am fully active or can carry out light work.I cannot swallow pills.My solid tumor cannot be surgically removed, has spread, and no effective treatments are left.I haven't taken strong medication affecting liver enzymes or certain transporters in the last 4 weeks.I haven't taken any cancer hormone therapy recently, except fulvestrant or abiraterone if I'm in specific study groups.My breast cancer is triple-negative and has worsened despite treatment.I have not had major surgery in the last 4 weeks or minor surgery in the last 7 days, and any surgical wounds have fully healed.I haven't taken certain medications that could interfere with the study treatment recently.My organs and bone marrow are working well.I am using birth control or my partner is.I have a history of lower GI disorders like IBD, ulcerative colitis, or Crohn's disease.I have had a transplant of an organ or stem cells.I can provide a sample of my tumor, either from previous or new biopsies.I have not taken XL102 or any similar medication.My side effects from previous treatments are mild or gone.I haven't had radiation therapy in the last 14 days and have no ongoing complications from previous treatments.I am not pregnant and can become pregnant.I have had major surgery on my stomach or intestines, or have a condition that affects how I absorb nutrients.I have not had serious bleeding, like a GI hemorrhage, in the last 3 months.My prostate cancer is primarily adenocarcinoma.Your heart's electrical activity, measured by ECG, shows a prolonged QT interval.Your doctor must be able to measure your disease using specific guidelines.My ovarian cancer does not respond to platinum-based chemotherapy anymore.
- Group 1: XL102 + Abiraterone/Prednisone Dose-Escalation Cohorts
- Group 2: XL102 + Fulvestrant Expansion Cohorts
- Group 3: XL102 Single-Agent Dose-Escalation Cohorts
- Group 4: XL102 Single-Agent Expansion Cohorts
- Group 5: XL102 + Fulvestrant Dose-Escalation Cohorts
- Group 6: XL102 + Abiraterone/Prednisone Expansion Cohorts
- 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
How precarious is the use of XL102 for patients?
"Given the limited data supporting safety and efficacy, XL102 receives a score of 1 on Power's risk evaluation scale."
What is the primary objective of this clinical investigation?
"This clinical study's main objective, measured over a 12 month period of time, is to determine the Maximum Tolerated Dose/Recommended Dose for XL102. The secondary endpoints include evaluating Safety (Incidence and Severity of Adverse Events), Tolerability (Study Treatment Exposure, Dosage Intensity & Modifications, Study Treatment Discontinuation due to AEs) and Apparent Clearance of XL102 alone or in combination with other therapies."
Are there any open opportunities to participate in this research?
"The information available through clinicaltrials.gov implies that this medical trial is actively seeking participants, with the initial posting occurring on February 10th 2021 and the most recent update coming April 19th 2022."
How many people are engaged in this research program?
"Exelixis, the sponsor of this study, requires a total of 298 qualified participants to carry out the trial. The company will be operating from two main locations- Exelixis Clinical Site #2 in Dallas and Exelixis Clinical Site #5 Houston."
Are there any existing investigations into the effects of XL102?
"At the moment, there are 498 different clinical trials running for XL102. Of these, 132 have progressed to Phase 3 of testing and most are located in Shanghai. However, there is a global presence with 23210 sites doing research on this medication."
How many sites are overseeing this research project?
"Patients hoping to participate in this trial can visit Exelixis Clinical Site #2 in Dallas, Exelixis Clinical Site #5 in Houston, and Exelixis Clinical Site #1 in San Antonio. There are 5 other enrolment locations available as well."
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