Selumetinib and Olaparib in Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 30, 2026 → Aug 30, 2028
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Record History

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  1. Primary and study completion pushed from Aug 30, 2026 to Aug 30, 2028 Show 4 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 23 words
    • Publications: details revised at 1 of 1 entry
  2. 9 versions Re-verified since Apr 10, 2023, no change to tracked fieldsv21-v29
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v20
  4. Primary and study completion dates: Aug 2026 to Aug 30, 2026v19
  5. 4 versions Re-verified since Jun 17, 2019, no change to tracked fieldsv15-v18
Show 13 earlier versionsHide 13 earlier versions
  1. Secondary endpoints: details revised at 1 of 3 entriesv14
  2. 2 versions Re-verified since Dec 21, 2018, no change to tracked fieldsv12-v13
  3. Study completion date: Aug 2027 to Aug 2026v11
  4. Site contact updatedv10
  5. Re-verified, no change to tracked fieldsv9
  6. Eligibility criteria expanded, about 4 wordsv8
  7. Study description expanded, about 9 wordsv7
  8. Study completion date: Aug 2026 to Aug 2027
    • Study description shortened, about 91 words
    v6
  9. Re-verified, no change to tracked fieldsv5
  10. Eligibility criteria shortened, about 2 wordsv4
  11. Re-verified, no change to tracked fieldsv3
  12. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary and study completion dates: Jul 2026 to Aug 2026
    • Start date changed from estimate of Jul 2017 to Aug 4, 2017
    • Eligibility criteria expanded, about 36 words
    • Study description shortened, about 12 words
    • Site details revised
  1. Study First Submitted
  • 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.
This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose combination of selumetinib and olaparib that can be given to patients who have solid tumors that are advanced or recurrent (has returned after treatment). The goal of Phase 2 is to learn if the highest tolerable dose combination found in Phase 1 can help to control advanced or recurrent solid tumors. The safety of the study drug combination will also be studied in both parts. This is an investigational study. Selumetinib is not FDA approved or commercially available. It is currently being used for research purposes only. Olaparib is FDA approved and commercially available for the treatment of ovarian cancer that has a certain type of genetic mutation (change). It is considered investigational to use selumetinib in combination with olaparib to treat advanced or recurrent cancer. The study doctor can explain how the study drugs are designed to work. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.
Trial Details
NCT Number NCT03162627
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Malignant Neoplasm of Breast, Malignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Male Genital Organs, Malignant Neoplasms of Thyroid and Other Endocrine Glands
Related terms Breast Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov