A Study of XL092 in Subjects With Solid Tumors
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/28/2019 |
Start Date: | February 2019 |
End Date: | February 2021 |
Contact: | Exelixis Clinical Trials |
Email: | druginfo@exelixis.com |
Phone: | 1-888-EXELIXIS (888-393-5494) |
A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors
This is a Phase 1, open-label, dose-escalation study, evaluating the safety, tolerability,
PK, preliminary antitumor activity, and effect on biomarkers of XL092 administered orally to
subjects with advanced solid tumors.
PK, preliminary antitumor activity, and effect on biomarkers of XL092 administered orally to
subjects with advanced solid tumors.
Inclusion Criteria:
- Cytologically or histologically confirmed solid tumor that is inoperable locally
advanced, metastatic, or recurrent.
- Dose-escalation: Subjects with a solid tumor that is unresectable or metastatic and
for which life-prolonging therapies do not exist or available therapies are
intolerable or no longer effective.
- Expansion Cohort A: Subjects with previously treated advanced RCC with clear cell or
non-clear cell histology who have radiographically progressed following treatment with
at least one prior systemic anticancer regimen for metastatic/advanced disease.
- Expansion Cohort B: Subjects with Stage IV NSCLC with non-squamous histology who have
radiographically progressed following treatment with at least two prior systemic
anticancer regimens for metastatic/advanced disease.
- Expansion Cohorts: Subjects must have measurable disease.
- Tumor tissue material (archival, if available, or fresh tumor tissue if it can be
safely obtained).
- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from toxicities related to any
prior treatments, unless AE(s) are clinically nonsignificant and/or stable on
supportive therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate organ and marrow function.
- Sexually active fertile subjects and their partners must agree to use medically
accepted methods of contraception.
- Female subjects of childbearing potential must not be pregnant at screening.
Exclusion Criteria:
- Receipt of any type of small molecule kinase inhibitor within 2 weeks before first
dose of study treatment
- Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal
anticancer therapy within 4 weeks before first dose of study treatment.
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy
within 4 weeks before first dose of study treatment. Subjects with clinically relevant
ongoing complications from prior radiation therapy are not eligible.
- Known brain metastases or cranial epidural disease unless adequately treated with
radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks
before first dose of study treatment.
- Uncontrolled, significant intercurrent or recent illness
- Concomitant use of certain medications
- Diagnosis of another malignancy within 2 years before first dose of study treatment,
except for superficial skin cancers, or localized, low grade tumors deemed cured and
not treated with systemic therapy.
- Pregnant or lactating females
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