Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

NCT00782574 | Completed Phase 1 DMC

• 2 other identifiers: D0810C000212008-000062-24
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumours; Poly(ADP ribose) polymerases; homologous deficiency; BRCA1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

AZD2281 DRUG

Tablets Oral BID

Also known as: Olaparib; Lynparza

1

Cisplatin DRUG

IV every 3 weeks

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Barcelona, 8035, Spain

Location

Related Links

• D0810C00021 redacted protocol
• CSR\_Synopsis\_D0810C00021.pdf

MeSH Terms

Interventions

olaparib; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jane Robertson, BSc, MBCHB, MD

  AstraZeneca

  STUDY DIRECTOR

• Judy E Garber

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• J Ballmana Gelpi

  Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: November 12, 2008
• Primary Completion: February 1, 2012
• Study Completion: December 7, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

US (2); ES (1)