Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a solid tumor that is unresectable or metastatic and for which life-prolonging measures do not exist or available therapies are intolerable or no longer effective.
Subjects with breast cancer that is hormone receptor-positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]) and negative for human epidermal growth factor receptor 2 (HER-2 negative [HER-2-]) and who have documented radiographic disease progression during or following their last systemic anticancer therapy for inoperable locally advanced or metastatic disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 30 months
Awards & highlights
Study Summary
This trial is testing a new drug called XL102 to see if it is safe and effective against solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that are inoperable or have spread, and who've run out of treatment options or can't tolerate existing ones. They must not be pregnant, should agree to use contraception, and have a good performance status (able to carry out daily activities). Specific criteria apply for breast cancer (HER-2 negative), prostate cancer, and ovarian cancer patients.Check my eligibility
What is being tested?
The study tests XL102 alone and combined with other drugs like Fulvestrant and Abiraterone in treating various cancers. It's an early-phase trial focusing on safety, how the body processes the drug(s), their effectiveness against tumors, and their impact on certain biological markers.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include nausea, fatigue, allergic reactions to medication components, potential organ inflammation due to immune responses triggered by treatments. The severity can range from mild symptoms to more serious complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My solid tumor cannot be surgically removed, has spread, and no effective treatments are left.
Select...
My breast cancer is hormone receptor-positive and HER-2 negative, and it has worsened despite treatment.
Select...
My cancer is confirmed, cannot be removed by surgery, and has spread or come back.
Select...
I am fully active or can carry out light work.
Select...
My breast cancer is triple-negative and has worsened despite treatment.
Select...
My organs and bone marrow are working well.
Select...
I am using birth control or my partner is.
Select...
I can provide a sample of my tumor, either from previous or new biopsies.
Select...
My side effects from previous treatments are mild or gone.
Select...
I am not pregnant and can become pregnant.
Select...
My prostate cancer is primarily adenocarcinoma.
Select...
My ovarian cancer does not respond to platinum-based chemotherapy anymore.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort-Expansion Stage: Objective Response Rate (ORR)
Dose-Escalation Stage: MTD/recommended dose for XL102
Secondary outcome measures
Dose-Escalation Stage: Apparent Clearance (CL/F)
Dose-Escalation Stage: Area Under the Plasma Concentration-Time Curve Over the Last 24-hour Dosing Interval (AUC 0-24)
Dose-Escalation Stage: Drug-Drug Interactions
+5 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: XL102 Single-Agent Expansion CohortsExperimental Treatment1 Intervention
The Maximum Tolerated Dose (MTD) or recommended dose from the dose-escalation stage may be further explored in subjects with triple-negative breast cancer (TNBC) (Cohort D), epithelial ovarian cancer (EOC) (Cohort E), hormone receptor-positive breast cancer (HR+ BC) (Cohort F), and metastatic castration-resistant prostate cancer (mCRPC) (Cohort G).
Group II: XL102 Single-Agent Dose-Escalation CohortsExperimental Treatment1 Intervention
Subjects will be separated into three separate groups of cohorts. Formulation A consists of: Fasted, with approximately 9 cohorts (A-FC) starting at 20 mg (qd and/or bid) of XL102, Food-Effect Dose-Escalation at 40 mg qd of XL102, with approximately 3 cohorts (A-FE) and Non-Fasted, with approximately 6 cohorts (A-NF).
Formulation B consists of additional cohorts: Fasted (A-FCFB) starting at 40 mg (qd and/or bid) of XL102 and Non-Fasted (A-NFCFB).
The dose of the remaining A-FE cohorts will be determined by the Cohort Review Committee (CRC) as well as that of the A-NF, and A-NFCFB cohorts.
Group III: XL102 + Fulvestrant Expansion CohortsExperimental Treatment2 Interventions
The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with HR+ BC (Cohort H).
Group IV: XL102 + Fulvestrant Dose-Escalation CohortsExperimental Treatment2 Interventions
Subjects with HR+ BC (Cohort B) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Group V: XL102 + Abiraterone/Prednisone Expansion CohortsExperimental Treatment3 Interventions
The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with mCRPC (Cohort I).
Group VI: XL102 + Abiraterone/Prednisone Dose-Escalation CohortsExperimental Treatment3 Interventions
Subjects with mCRPC (Cohort C) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Abiraterone
2012
Completed Phase 4
~2830
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
ExelixisLead Sponsor
117 Previous Clinical Trials
19,178 Total Patients Enrolled
1 Trials studying Ovarian Cancer
1,732 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger