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PARP Inhibitor
Olaparib + Sapacitabine for Breast Cancer
Phase 1
Waitlist Available
Led By Sara M. Tolaney, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants enrolling to the phase I portion of the study must have evaluable or measurable disease
Patients with HER2-positive disease must have received and progressed on two lines of HER2-directed therapy in the metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from the time of the first patient registration to the time that the last patient comes off protocol therapy, up to 41 months
Awards & highlights
Study Summary
This trial is attempting to find a more effective treatment for breast cancer, specifically for those with a BRCA mutation. The study will be testing a combination of two drugs, sapacitabine and olaparib, to see if they are more effective than either drug used alone.
Who is the study for?
This trial is for adults with metastatic or unresectable breast cancer that has a BRCA mutation. Candidates must have progressed after certain therapies, depending on their cancer type. They should be able to take oral medication and agree to use effective contraception. People with recent treatments, active hepatitis or HIV, heart issues, prior PARP inhibitor treatment, MDS/AML history, major surgery complications within 2 weeks before the study start are excluded.Check my eligibility
What is being tested?
The study tests a combination of two drugs: Sapacitabine (CYC682) and Olaparib (Lynparza™), as potential treatments for breast cancer with BRCA mutations. It's structured in phases; phase I evaluates safety while phase II measures how well the disease responds according to RECIST criteria.See study design
What are the potential side effects?
Potential side effects include risks during pregnancy hence contraception requirements; organ inflammation; digestive disturbances due to oral intake of medication; blood disorders from bone marrow impact; fatigue from overall drug effects on body function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured or seen on tests.
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My HER2-positive cancer has worsened after two different HER2 treatments.
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My breast cancer is confirmed and cannot be removed by surgery.
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I can swallow and keep down pills.
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I agree to use two effective birth control methods during the study and for 6 months after.
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My cancer is hormone receptor-positive and has worsened despite hormone therapy.
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I am 18 years old or older.
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I am a woman who is either postmenopausal or not currently pregnant.
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I am fully active or can carry out light work.
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I am willing and able to follow the study's treatment and visit schedule.
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I have a harmful BRCA1 or BRCA2 gene mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from the time of the first patient registration to the time that the last patient comes off protocol therapy, up to 41 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from the time of the first patient registration to the time that the last patient comes off protocol therapy, up to 41 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Objective Response Rate
Recommended Phase II dose (RPIID)
Secondary outcome measures
Dose Limiting Toxicity
Progression-Free Survival
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Level 3: Sapacitabine (250 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions
Olaparib will be administered orally twice daily for each 28-day cycle
Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
Group II: Dose Level 2: Sapacitabine (200 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions
Olaparib will be administered orally twice daily for each 28-day cycle
Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
Group III: Dose Level 1: Sapacitabine (150 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions
Olaparib will be administered orally twice daily for each 28-day cycle
Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
Group IV: Dose Level -1: Sapacitabine (100 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions
Olaparib will be administered orally twice daily for each 28-day cycle
Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapacitabine
2011
Completed Phase 3
~490
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,232 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,329 Patients Enrolled for Breast Cancer
Cyclacel Pharmaceuticals, Inc.Industry Sponsor
19 Previous Clinical Trials
2,469 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,938 Total Patients Enrolled
141 Trials studying Breast Cancer
22,607 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had more than 3 chemotherapy treatments for my cancer after it spread.I do not have any uncontrolled illnesses.My organs and bone marrow are working well.Your heart's electrical activity measures more than 470 milliseconds on a screening test.My cancer can be measured or seen on tests.I am not taking strong or moderate CYP3A inhibitors.I have had another type of cancer before.My HER2-positive cancer has worsened after two different HER2 treatments.I have never been treated with sapacitabine.I cannot swallow pills or have a stomach condition that affects medication absorption.I am allergic to medications similar to sapacitabine or olaparib.My breast cancer is confirmed and cannot be removed by surgery.I can swallow and keep down pills.I agree to use two effective birth control methods during the study and for 6 months after.My cancer is hormone receptor-positive and has worsened despite hormone therapy.I am 18 years old or older.I am willing to have a biopsy if my condition allows it.I am a man and agree to use two effective birth control methods during and 3 months after the study.I am a woman who is either postmenopausal or not currently pregnant.I have a history of or signs pointing to blood disorders like MDS or AML.I or someone in my family has long QT syndrome.I currently have inflammation in my lungs.I have had a bone marrow or cord blood transplant in the past.I haven't had chemotherapy, immune therapy, or experimental treatments in the last 3 weeks.I have active Hepatitis B, C, or am HIV positive.I have never been treated with a PARP inhibitor like olaparib.I am fully active or can carry out light work.I haven't had major surgery or ongoing health issues from treatment in the last 2 weeks.If you're joining the phase II part of the study, your disease must be measurable according to specific criteria.I have not had radiotherapy in the last week.I have had brain metastases but meet all specified treatment criteria.I am willing and able to follow the study's treatment and visit schedule.I have a harmful BRCA1 or BRCA2 gene mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 2: Sapacitabine (200 mg) + Olaparib (300 mg)
- Group 2: Dose Level 3: Sapacitabine (250 mg) + Olaparib (300 mg)
- Group 3: Dose Level -1: Sapacitabine (100 mg) + Olaparib (300 mg)
- Group 4: Dose Level 1: Sapacitabine (150 mg) + Olaparib (300 mg)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this undertaking the inaugural attempt at such a study?
"Currently, 188 clinical trials are ongoing for Olaparib across 1469 cities and 60 countries. The first study commenced in 2005 under the auspices of AstraZeneca with 98 participants and achieved Phase 1 approval. Since then, 67 additional studies have been conducted."
Answered by AI
Is there any existing evidence of Olaparib's effectiveness from prior investigations?
"At present, there are 188 ongoing clinical trials on Olaparib with 27 of them in the final Phase 3. Ann Arbor, Michigan has several studies dedicated to this pharmaceutical agent; however, it is being tested at 9255 other sites globally as well."
Answered by AI
What medical conditions can Olaparib be used to manage?
"Olaparib is an efficacious remedy for advance directives, malignant neoplasms of the ovary, and primary peritoneal cancer."
Answered by AI
Are participants being sought out for this experiment?
"Clinicaltrials.gov has stated that this trial, which was posted to the site on October 1st 2018 and last amended on May 2nd 2022, is not actively recruiting participants presently. However, there are myriad other medical trials accepting applicants at present - 2788 in total."
Answered by AI
What potential risks exist with Olaparib treatment?
"Olaparib's safety has been established to a limited degree, thus it scored a 1 on the Power scale. This is because this study is in its initial phases and there exists only fragmentary evidence of efficacy and safety."
Answered by AI
How many subjects has this experiment recruited so far?
"Currently, enrollment has been suspended in this particular clinical trial. It was listed on October 1st 2018 and last updated on May 2nd 2022. If you are seeking alternative medical studies, 2600 trials for breast cancer and 188 investigations involving Olaparib are actively recruiting patients."
Answered by AI
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