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PARP Inhibitor

AZD2281 + Cisplatin for Advanced Cancer

Phase 1
Waitlist Available
Led By J Ballmana Gelpi
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly visits for routine monitoring visits
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat advanced solid tumors. The goal is to find the maximum tolerated dose of the new drug combination. Approximately 50 patients from 2 countries will be enrolled.

Who is the study for?
This trial is for patients with advanced solid tumors that can't be removed by surgery or treated with radiation to cure them. Participants must have a life expectancy of at least 12 weeks and measurable disease as defined by RECIST criteria.Check my eligibility
What is being tested?
The study is testing the safety and best dose of AZD2281 when used together with Cisplatin in people with advanced solid tumors. It's an early-phase, open-label trial involving up to 60 patients from two countries.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, kidney damage from Cisplatin, and gastrointestinal symptoms, fatigue, blood count changes due to AZD2281. The exact side effects will be studied as part of this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at screening, visit 9, and at end of every 2 cycles
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at screening, visit 9, and at end of every 2 cycles for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).
Cisplatin

Side effects data

From 2018 Phase 2 trial • 97 Patients • NCT00628251
59%
Nausea
38%
Abdominal Pain
38%
Fatigue
34%
Vomiting
28%
Constipation
25%
Diarrhoea
25%
Headache
19%
Asthenia
19%
Cough
16%
Upper Respiratory Tract Infection
16%
Decreased Appetite
16%
Dyspepsia
16%
Urinary Tract Infection
16%
Dysgeusia
16%
Leukopenia
13%
Hot Flush
13%
Anaemia
13%
Oropharyngeal Pain
9%
Rash
9%
Back Pain
9%
Arthralgia
9%
Alopecia
9%
Abdominal Distension
9%
Influenza
9%
Insomnia
6%
Myalgia
6%
Hypomagnesaemia
6%
Muscle Spasms
6%
Musculoskeletal Pain
6%
Cerebrovascular Accident
6%
Thrombocytopenia
6%
Viral Infection
6%
Hypotension
6%
Nasopharyngitis
6%
Weight Decreased
6%
Flatulence
6%
Oedema Peripheral
6%
Flank Pain
6%
Dizziness
6%
Neuropathy Peripheral
6%
Memory Impairment
6%
Ascites
6%
Neutropenia
6%
Anxiety
6%
Dyspnoea
3%
Myelodysplastic Syndrome
3%
Dry Skin
3%
Intestinal Obstruction
3%
Musculoskeletal Chest Pain
3%
Bronchitis
3%
Haemorrhoids
3%
Pyrexia
3%
Gastrooesophageal Reflux Disease
3%
Syncope
3%
Abdominal Pain Upper
3%
Body Temperature Increased
3%
Pain In Extremity
3%
Groin Pain
3%
Oral Pain
3%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 200 mg bd
Olaparib 400 mg bd
Liposomal Doxorubicin

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2281
2008
Completed Phase 2
~560
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,262 Previous Clinical Trials
288,595,185 Total Patients Enrolled
J Ballmana GelpiPrincipal InvestigatorVall d'Hebron
Judy E GarberPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the usual therapeutic applications of AZD2281?

"AZD2281 is a preferred treatment for advanced testicular cancer, as well as other conditions such as pharmacotherapy-resistant ovarian cancer and refractory to standard therapies."

Answered by AI

Has AZD2281 received the requisite governmental authorization for sale?

"As this is an early-phase trial, with limited safety data and efficacy studies conducted, AZD2281 was rated as a 1 on our team's scale."

Answered by AI

Who is likely to be the most suitable candidate for this experiment?

"This trial requires 57 applicants with solid tumors, metastatic neoplasms of any type aged between 18 to 99. Eligibility is determined by RECIST standards and an estimated life expectancy of at least 3 months."

Answered by AI

Is this research project currently in search of participants?

"At present, this clinical trial is not actively seeking participants. Initially posted on November 12th 2008 and with its most recent update occurring October 4th 2022, it has since ceased to recruit patients. Nonetheless, there are plenty of other options; 2503 trials for solid tumors and advanced cases thereof as well as 869 AZD2281 studies that remain open."

Answered by AI

Could you provide some information about the other research studies that have employed AZD2281?

"AZD2281 has 869 live clinical trials, of which 299 are in Phase 3. Most studies for this drug are conducted in Shanghai, though other locations across the world have 51934 active research sites."

Answered by AI

Are mature participants eligible for this clinical investigation?

"The upper limit of eligibility for this trial is set at 99 years old, while the lower bound requires patients to be over 18."

Answered by AI

What is the scope of participants in this medical trial?

"This clinical trial is no longer admitting candidates. It was initially posted in November of 2008 and the information was last updated on October 4th 2022. If you are hoping to participate in a different study, there are currently 2503 trials recruiting people with solid tumors or advanced solid tumors, as well as 869 studies seeking participants for AZD2281."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients
2008. "Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00782574.
~3 spots leftby Apr 2025
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