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A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

Study acronym: STELLAR-001
StatusActive, Not Recruiting
PhasePhase 1
SponsorExelixis
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 19, 2024 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Nov 2024 to Aug 31, 2026 Study sites: 84 to 86 · Completion date: Nov 2024 to May 31, 2027v28 Show 2 more changesShow less
    • Study sites: 84 to 86
    • Completion date: Nov 2024 to May 31, 2027
  2. Primary completion date: Nov 2023 to Nov 2024v27
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 921 to confirmed 325 · Study sites: 80 to 84v26 Show 2 more changesShow less
    • Enrollment target: estimated 921 to confirmed 325
    • Study sites: 80 to 84
  4. Enrollment target: 1195 to 921 Eligibility criteria shortened, about 135 words · Study sites revised (80) · Study arms: 6 to 5v25 Show 3 more changesShow less
    • Eligibility criteria shortened, about 135 words
    • Study sites revised (80)
    • Study arms: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 80 sitesv24
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites: 70 to 80v23
  2. Study sites: 66 to 70v22
  3. Study sites: 62 to 66v21
  4. Primary endpoints: 3 to 4 Enrollment target: 800 to 1195 · Study sites: 60 to 62 · Eligibility criteria expanded, about 64 wordsv20 Show 3 more changesShow less
    • Enrollment target: 800 to 1195
    • Study sites: 60 to 62
    • Eligibility criteria expanded, about 64 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 56 to 60v19
  6. Study sites: 44 to 56v18
  7. Study sites: 40 to 44v17
  8. Study sites: 19 to 40v16
  9. Study sites: 15 to 19v15
  10. Study sites: 9 to 15v14
  11. Study sites: 7 to 9v13
  12. Re-verified, no change to tracked fieldsv12
  13. Enrollment target: 425 to 800 Primary completion date: May 2022 to Nov 2023 · Primary endpoints: 2 to 3 · Completion date: May 2022 to Nov 2024 · 4 morev11 Show 7 more changesShow less
    • Primary completion date: May 2022 to Nov 2023
    • Primary endpoints: 2 to 3
    • Completion date: May 2022 to Nov 2024
    • Interventions: Atezolizumab (Drug), XL092 (Drug) to Atezolizumab (Drug), Avelumab (Drug), XL092 (Drug)
    • Eligibility criteria expanded, about 205 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study arms: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 6 to 7v10
  15. Enrollment target: 151 to 425 Primary and study completion dates: Feb 2021 to May 2022 · Primary endpoints: 3 to 2 · Interventions: XL092 (Drug) to Atezolizumab (Drug), XL092 (Drug) · 4 morev9 Show 7 more changesShow less
    • Primary and study completion dates: Feb 2021 to May 2022
    • Primary endpoints: 3 to 2
    • Interventions: XL092 (Drug) to Atezolizumab (Drug), XL092 (Drug)
    • Eligibility criteria expanded, about 171 words
    • Secondary endpoints: 1 to 6
    • Study arms: 2 to 4
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 4 to 6v8
  17. Enrollment target: 100 to 151 Eligibility criteria expanded, about 47 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 47 words

    See this version in full on ClinicalTrials.gov ↗

  18. Start date: Feb 26, 2019 to Mar 20, 2019v6
  19. Site details revised at 1 of 4 sitesv5
  20. Start date changed from estimate of Feb 2019 to Feb 26, 2019 Site details revised at 1 of 4 sitesv4 Show 1 more changeShow less
    • Site details revised at 1 of 4 sites
  21. Site details revised at 4 of 4 sitesv3
  22. Trial status: Not Yet Recruiting to Recruiting Site details revised at 4 of 4 sitesv2 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Exelixis
25 trials monitored
See 2 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
and 1 more disease
This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.
Trial Details
NCT Number NCT03845166
Lead Sponsor Exelixis
Conditions Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer, Colorectal Cancer
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov