What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as olaparib and niraparib, often result in side effects including nausea, fatigue, vomiting, and anemia. Chemotherapy agents like paclitaxel and carboplatin can cause peripheral neuropathy, myelosuppression, and gastrointestinal disturbances. These side effects are generally manageable but can impact the patient's quality of life. Investigational drugs like XL102, which are being studied for their antitumor activity, may have similar or additional side effects, but specific data on XL102 is not yet available.

What prior FDA approvals exist?

Several FDA-approved drugs have shown antitumor activity in the treatment of ovarian cancer. Notable among these are PARP inhibitors such as olaparib, niraparib, and rucaparib, which are used as maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer. Bevacizumab, an angiogenesis inhibitor, is also approved for use in combination with chemotherapy for recurrent ovarian cancer. Additionally, pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has been approved for use in certain cases of ovarian cancer with specific genetic markers. These treatments have demonstrated efficacy in clinical trials and are part of the evolving landscape of ovarian cancer therapy.

What other types of research exist?

Promising novel alternatives to XL102 for ovarian cancer patients include: <ol> <li>Olaparib: A PARP inhibitor shown to improve progression-free survival in patients with BRCA mutations.</li> <li></li> </ol> Niraparib: Another PARP inhibitor effective in platinum-sensitive recurrent ovarian cancer. 3. Rucaparib: Effective as both maintenance therapy and monotherapy for recurrent, platinum-sensitive ovarian cancer. 4. Bevacizumab: An anti-angiogenic agent used in combination with chemotherapy for advanced ovarian cancer. 5. Selpercatinib: A selective RET inhibitor showing efficacy in RET-altered cancers, including ovarian cancer.

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Other

XL102 Combination Therapy for Cancer

Phase 1

Waitlist Available

Research Sponsored by Exelixis

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.

Must not have

Uncontrolled, significant intercurrent or recent illness.

Active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, acute or chronic hepatitis B or C infection, or a known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease. Prophylactic use of antibiotics is allowed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called XL102 to see if it can help treat advanced cancers. The study focuses on patients whose cancer has progressed significantly. Researchers are looking at how safe the drug is, how well patients can handle it, and if it can stop or reduce tumor growth.

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.

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.

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 below

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My solid tumor cannot be surgically removed, has spread, and no effective treatments are left.

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My breast cancer is hormone receptor-positive and HER-2 negative, and it has worsened despite treatment.

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My cancer is confirmed, cannot be removed by surgery, and has spread or come back.

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I am fully active or can carry out light work.

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My breast cancer is triple-negative and has worsened despite treatment.

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I am not pregnant and can become pregnant.

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My ovarian cancer does not respond to platinum-based chemotherapy anymore.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses that are not under control.

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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.

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My liver function is significantly impaired.

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I require dialysis treatment.

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I haven't had chemotherapy or antibody therapy in the last 21 days.

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I cannot swallow pills.

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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.

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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.

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I have a history of lower GI disorders like IBD, ulcerative colitis, or Crohn's disease.

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I have had a transplant of an organ or stem cells.

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I have not taken XL102 or any similar medication.

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I haven't had radiation therapy in the last 14 days and have no ongoing complications from previous treatments.

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I have had major surgery on my stomach or intestines, or have a condition that affects how I absorb nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort-Expansion Stage: Objective Response Rate (ORR)

Dose-Escalation Stage: MTD/recommended dose for XL102

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~3520

Abiraterone

2012

Completed Phase 4

~4570

Prednisone

2014

Completed Phase 4

~2500

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include platinum-based chemotherapies (e.g., carboplatin and cisplatin), which cause DNA cross-linking and damage, leading to cell death. PARP inhibitors (e.g., olaparib, niraparib) prevent DNA repair in cancer cells, particularly effective in those with BRCA mutations. Bevacizumab, a targeted therapy, inhibits angiogenesis by blocking VEGF, reducing tumor blood supply. These mechanisms are crucial as they target cancer cell survival and proliferation pathways. Investigational drugs like XL102, which exhibit antitumor activity, may offer new avenues by potentially targeting similar or complementary pathways, providing hope for more effective treatments.

Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.