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A Study of XL092 in Subjects With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845166
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Exelixis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Renal Cell Carcinoma Non Small Cell Lung Cancer Drug: XL092 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: dose-escalation followed by dose expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: XL092 Dose-Escalation Cohorts
Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.
Drug: XL092
oral doses of XL092

Experimental: XL092 Dose Expansion Cohorts
The MTD or recommended dose from the dose-escalation stage will be further explored.
Drug: XL092
oral doses of XL092




Primary Outcome Measures :
  1. MTD/recommended dose for XL092 [ Time Frame: Up to 12 months ]
    To determine the maximum tolerated dose (MTD) and/or recommended dose

  2. Pharmacokinetics of XL092 [ Time Frame: Up to 24 months ]
    To evaluate the plasma pharmacokinetics of XL092

  3. Safety and tolerability of XL092 assessed through the evaluation of dose-limiting toxicities and the incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 24 months ]
    To assess safety of XL092 through the evaluation of dose-limiting toxicities and the incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. Preliminary activity of XL092 [ Time Frame: Up to 24 months ]
    To evaluate the preliminary antitumor activity of XL092 as assessed by objective responses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Cohort C: Subjects with metastatic CRPC (adenocarcinoma of the prostate) who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease. Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
  • 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 adverse events (AEs), including immune-related adverse events (irAEs), 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845166


Contacts
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Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400

Locations
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United States, California
Exelixis Clinical Site #6 Recruiting
Duarte, California, United States, 91010
United States, Massachusetts
Exelixis Clinical Site #4 Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Exelixis Clinical Site #2 Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Texas
Exelixis Clinical Site #3 Recruiting
Houston, Texas, United States, 77030
Exelixis Clinical Site #1 Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Exelixis Clinical Site #5 Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Exelixis

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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT03845166    
Other Study ID Numbers: XL092-001
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms
Neoplasms by Site
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases