PARP Inhibitor
Olaparib for Stomach Cancer
University of Colorado Health, Aurora, CO
Targeting 2 different conditionsOlaparib +2 morePhase 2RecruitingLed by Sunnie S Kim, MDResearch Sponsored by University of Colorado, DenverEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have a primary tumor or a single metastatic site amenable to radiation in: the stomach, esophagus, liver, lungs, pancreas, thoracic/abdominal LNs, or soft tissues. Of note - sites of disease planned to be biopsied should not be radiated.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new cancer treatment that combines two existing treatments. The first part of the trial is to make sure the treatment is safe, and then they will assess how well it works.
Eligible Conditions
- Stomach Cancer
- Gastroesophageal Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have cancer in one specific site that can be treated with radiation. The site should not be the same one planned for biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) of unirradiated tumors
Secondary outcome measures
Disease Control Rate (DCR) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Duration of Response (DOR) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 during concurrent SBRT/olaparib
+2 moreSide effects data
From 2021 Phase 4 trial • 181 Patients • NCT0247696856%
Nausea
44%
Anaemia
44%
Fatigue
28%
Vomiting
17%
Diarrhoea
16%
Dyspepsia
15%
Asthenia
15%
Dizziness
14%
Neutropenia
13%
Arthralgia
13%
Headache
13%
Abdominal pain
11%
Decreased appetite
10%
Nasopharyngitis
10%
Cough
10%
Abdominal pain upper
10%
Dyspnoea
9%
Blood creatinine increased
9%
Dysgeusia
8%
Back pain
8%
Insomnia
8%
Influenza like illness
8%
Influenza
8%
Alanine aminotransferase increased
8%
Alopecia
7%
Hypomagnesaemia
7%
Abdominal distension
7%
Pyrexia
7%
Leukopenia
6%
Neutrophil count decreased
6%
Constipation
6%
Platelet count decreased
6%
Peripheral swelling
6%
Thrombocytopenia
6%
Bronchitis
6%
Urinary tract infection
6%
White blood cell count decreased
5%
Anxiety
5%
Musculoskeletal pain
5%
Myalgia
5%
Pain in extremity
5%
Depression
5%
Pruritus
3%
Pulmonary embolism
3%
Abdominal pain lower
3%
Gastrooesophageal reflux disease
3%
Rash
3%
Hypertension
3%
Oropharyngeal pain
2%
Acute myeloid leukaemia
2%
Upper respiratory tract infection
2%
Vitamin d deficiency
2%
Glomerular filtration rate decreased
1%
Non-hodgkin's lymphoma
1%
Transient ischaemic attack
1%
Burkitt's lymphoma
1%
Abdominal hernia
1%
Papillary thyroid cancer
1%
Mesenteric vein thrombosis
1%
Sudden death
1%
Procedural pain
1%
Drug hypersensitivity
1%
Sepsis
1%
Myelodysplastic syndrome
1%
Oral candidiasis
1%
Deep vein thrombosis
1%
Subileus
1%
Angina unstable
1%
Lower respiratory tract infection
1%
Glaucoma
1%
Haemorrhoids
1%
Mucosal inflammation
100%
80%
60%
40%
20%
0%
Study treatment Arm
gBRCAm
sBRCAm
Overall BRCAm
HRRm
Unassigned (Not BRCAm, Not HRRm^)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: HR proficient cohortExperimental Treatment3 Interventions
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway
Group II: HR deficient cohortExperimental Treatment3 Interventions
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~770
Pembrolizumab
2017
Completed Phase 3
~2210
Olaparib
2017
Completed Phase 4
~1430
Find a site
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,775 Previous Clinical Trials
4,985,006 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,661 Previous Clinical Trials
1,662,042 Total Patients Enrolled
Sunnie S Kim, MDPrincipal Investigator
University of Colorado, DenverMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the safeness profile of Olaparib for those undergoing treatment?
"Olaparib is believed to be moderately safe, and thus earned a score of 2. This assessment was made given that the drug has yet to pass efficacy testing though there is some evidence corroborating its safety profile."
Answered by AI
Does this research endeavor permit those aged thirty and above to participate?
"As per the requirements of this clinical trial, individuals must be aged 18 or older but no more than 100 years old."
Answered by AI
Who are the ideal candidates for this trial?
"This clinical trial is enrolling 26 individuals aged 18 to 100 suffering from gastroesophageal cancer. In order for patients to be eligible, they must meet the following requirements: being of legal age; having a primary tumor or an isolated metastatic site amenable to radiation in their stomach, esophagus, liver, lungs, pancreas thoracic/abdominal lymph nodes or soft tissues (biopsied sites should not be radiated); undergoing NGS testing at a CLIA certified laboratory with CAP tested and bioinformatics-validated protocols prior starting treatment; signing and dating the consent form; possessing one"
Answered by AI
Is there currently any opportunity to enroll in this clinical trial?
"According to its clinicaltrials.gov page, this trial has closed recruitment as of May 19th 2022. However, there are still 643 other trials actively searching for candidates at the present moment."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
65+
What site did they apply to?
University of Colorado Health
What portion of applicants met pre-screening criteria?
Met criteria