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Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later May 15, 2027 → Sep 30, 2028
Primary endpoint added 2 → 3 primary endpoints
See other at-risk trials from Revolution Medicines, Inc.

Record History

  1. Primary completion pushed from May 15, 2027 to Sep 30, 2028 Primary endpoint(s) modified · Completion pushed from Jul 15, 2027 to Mar 30, 2030 · Interventions modified · 6 more Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Completion pushed from Jul 15, 2027 to Mar 30, 2030
    • Interventions modified
    • Trial arms changed: 6 → 7
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 7 to 11
    • Study description expanded, about 6 words
    • Site details revised at 3 of 32 sites
    • Publications: details revised at 1 of 1 entry
  2. Site contacts updated at 1 of 32 sitesv33
  3. Site contacts updated at 1 of 32 sitesv32
  4. Site contacts updated at 1 of 32 sitesv31
  5. Site contacts updated at 1 of 32 sitesv30
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites: 31 to 32v29
  2. Study sites: 30 to 31v28
  3. Study sites: 29 to 30v27
  4. Study sites: 28 to 29v26
  5. Site contacts updated at 2 of 28 sitesv25
  6. Study sites: 27 to 28v24
  7. Study sites: 25 to 27v23
  8. Study sites: 24 to 25v22
  9. Study sites: 23 to 24v21
  10. Study sites: 22 to 23v20
  11. Site contacts updated at 2 of 22 sitesv19
  12. Study sites: 21 to 22v18
  13. Site contacts updated at 3 of 21 sitesv17
  14. Study sites: 18 to 21v16
  15. Site contacts updated at 1 of 18 sitesv15
  16. Enrollment target: 406 to 1130 Study sites: 17 to 18 · Interventions: RMC-6236 (Drug), bevacizumab (Drug), cetuximab (Drug), gemcitabine (Drug), mFOLFIRINOX regimen (Drug), mFOLFOX6 regimen (Drug)… to RMC-6236 (Drug), RMC-9805 (Drug), bevacizumab (Drug), cetuximab (Drug), gemcitabine (Drug), mFOLFIRINOX regimen (Drug), mFOLFOX6 regimen… · Eligibility criteria expanded, about 9 words · 3 morev14 Show 6 more changesShow less
    • Study sites: 17 to 18
    • Interventions: RMC-6236 (Drug), bevacizumab (Drug), cetuximab (Drug), gemcitabine (Drug), mFOLFIRINOX regimen (Drug), mFOLFOX6 regimen (Drug)… to RMC-6236 (Drug), RMC-9805 (Drug), bevacizumab (Drug), cetuximab (Drug), gemcitabine (Drug), mFOLFIRINOX regimen (Drug), mFOLFOX6 regimen…
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 98 words
    • Study arms: 3 to 6

    See this version in full on ClinicalTrials.gov ↗

  17. Site contacts updated at 5 of 17 sitesv13
  18. Study sites: 16 to 17v12
  19. Study sites: 15 to 16v11
  20. Study sites: 14 to 15v10
  21. Study sites: 13 to 14v9
  22. Re-verified, no change to tracked fieldsv8
  23. Study sites: 11 to 13v7
  24. Study sites: 10 to 11v6
  25. Study sites: 8 to 10v5
  26. Study sites: 7 to 8v4
  27. Study sites: 5 to 7v3
  28. Study sites: 2 to 5 Eligibility criteria shortened, about 10 words · Study description expanded, about 9 wordsv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 10 words
    • Study description expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  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.
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol G: RMC-9805 + cetuximab + FOLFIRI
Trial Details
NCT Number NCT06445062
Lead Sponsor Revolution Medicines, Inc.
Conditions Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC, Gastrointestinal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma
Enrollment 1,130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov