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NCT00782574 Clinical Trial

Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

Advanced Solid Tumors Clinical Trial

Official title:
A Phase I Open Label, Multi Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00782574
Other study ID # D0810C00021
Secondary ID 2008-000062-24
Status Completed
Phase Phase 1
First received
Last updated
Start date November 12, 2008
Est. completion date December 7, 2023

Study information
Verified date December 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date December 7, 2023
Est. primary completion date February 1, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Life expectancy of at least 12 weeks - Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent - Patients with measurable or non measurable disease according to RECIST Exclusion Criteria: - Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy - Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for >1 week - Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2281
Tablets Oral BID
• Cisplatin
IV every 3 weeks

Locations
Country Name City State
Spain Research Site Barcelona
United States Research Site Boston Massachusetts
United States Research Site Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Weekly visits for routine monitoring visits
Secondary To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281). PK samples taken at visit 2 and 3
Secondary To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate. Assessed at screening, visit 9, and at end of every 2 cycles
See also
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Completed NCT05086822 - A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors Phase 1
Completed NCT03260322 - A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
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Terminated NCT03665129 - IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors Phase 1
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Completed NCT01693562 - A Phase 1/2 Study to Evaluate MEDI4736 Phase 1/Phase 2
Recruiting NCT04387916 - A Study of KC1036 in Patients With Advanced Solid Tumors Phase 1
Completed NCT04095273 - Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug Phase 1
Not yet recruiting NCT03692520 - Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors Phase 1
Completed NCT02997176 - An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Phase 1
Recruiting NCT04446260 - A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors Phase 1
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT02253992 - An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Recruiting NCT06076291 - An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors Phase 1
Completed NCT03545971 - A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors. Phase 1

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