A Phase 1 interventional study of AZD2281 and Cisplatin in Advanced Solid Tumors, sponsored by AstraZeneca. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 57 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.
Drug: AZD2281 · Drug: Cisplatin
Tablets Oral BID
Also known as: Olaparib; Lynparza
IV every 3 weeks
To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.
Time frame: Weekly visits for routine monitoring visits
To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).
Time frame: PK samples taken at visit 2 and 3
To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate.
Time frame: Assessed at screening, visit 9, and at end of every 2 cycles
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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