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)

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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.


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
We found this trial at
4
sites
Boston, Massachusetts 02215
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Boston, MA
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Grand Rapids, Michigan 49546
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Grand Rapids, MI
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Houston, Texas 77030
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Houston, TX
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San Antonio, Texas 78229
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San Antonio, TX
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