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PARP Inhibitor

Olaparib + Vorinostat for Breast Cancer

Phase 1
Recruiting
Led By Jenny Chang, M.D.
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed relapsed/refractory and/or metastatic breast cancer with the exception of human epidermal growth factor receptor 2-positive breast cancer
Female or male ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of two drugs, olaparib and vorinostat, when used together to treat breast cancer that has returned or spread.

Who is the study for?
This trial is for adults with relapsed/refractory or metastatic breast cancer, excluding those with HER2-positive type. Participants must have a life expectancy of at least 6 months, good organ and bone marrow function, and be willing to use effective contraception. They should not have pneumonitis, uncontrolled brain metastases, known drug hypersensitivity, recent blood transfusions or chemotherapy, certain heart conditions or infections.Check my eligibility
What is being tested?
The study tests the combination of two drugs: Olaparib and Vorinostat in patients whose breast cancer has returned after treatment or spread elsewhere. It aims to determine the safety and initial effectiveness of this drug duo.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, anemia (low red blood cell count), risk of infection due to low white blood cells, changes in taste sensation (dysgeusia), diarrhea or constipation. There could also be more serious risks like lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has returned or spread and is not HER2-positive.
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I am 18 years old or older.
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I am willing to have a biopsy for the study.
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I am a male and agree to use condoms during the study and for 3 months after.
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I am postmenopausal or not able to bear children, confirmed by a recent negative pregnancy test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organ and bone marrow functions are normal as tested within the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD
Secondary outcome measures
Antitumor activity
Dose-limiting toxicities (DLTs) and other adverse events
Recommended Phase 2 dose (RP2D)

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
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%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
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%
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%
General physical health deterioration
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

1Treatment groups
Experimental Treatment
Group I: Olaparib and VorinostatExperimental Treatment2 Interventions
Phase I: Olaparib and vorinostat will be orally administered for 4 28-day cycles. Dose levels (DLs) are as follows: DL -1, 100 mg twice daily (b.i.d.) olaparib and 300 mg for 5 consecutive days per week vorinostat; DL 0 (starting dose), 200 mg twice daily (b.i.d.) olaparib and 300 mg once daily (q.d.) vorinostat; DL 1, 300 mg b.i.d. olaparib and 300 mg q.d. vorinostat; and DL 2, 300 mg b.i.d. olaparib and 400 mg q.d. vorinostat. Phase Ib: Olaparib and vorinostat will be administered at the maximum tolerated dose (MTD) determined in the Phase I portion of the study for 4 28-day cycles. Participants who derive clinical benefit (complete response, partial response, or stable disease) after 4 cycles will continue to receive study treatment until unacceptable toxicity or disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Vorinostat
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,245 Previous Clinical Trials
288,529,260 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,311 Patients Enrolled for Breast Cancer
The Methodist Hospital Research InstituteLead Sponsor
270 Previous Clinical Trials
80,220 Total Patients Enrolled
12 Trials studying Breast Cancer
323 Patients Enrolled for Breast Cancer
Jenny Chang, M.D.Principal InvestigatorHouston Methodist Cancer Center
2 Previous Clinical Trials
69 Total Patients Enrolled
1 Trials studying Breast Cancer
39 Patients Enrolled for Breast Cancer

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03742245 — Phase 1
Breast Cancer Research Study Groups: Olaparib and Vorinostat
Breast Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03742245 — Phase 1
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03742245 — Phase 1

Frequently Asked Questions

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

What is the risk profile for Olaparib usage?

"Olaparib's safety was rated a 1, as there is limited evidence to demonstrate its efficacy and little data to confirm it is safe."

Answered by AI

What afflictions may be addressed with Olaparib?

"Olaparib can be therapeutically applied to cases of advanced cutaneous T-cell lymphoma, ctage1 protein, human physiology and pharmacological treatments."

Answered by AI

Have any investigations been carried out with Olaparib in the past?

"At this time, there are 217 trials involving Olaparib. Of these studies, 29 of them are in their final phase. The primary location for such research is Phoenix, Arizona; however a multitude of other sites also offer the experimental treatment to participants."

Answered by AI

What is the number of participants that have been recruited to this research endeavor?

"Indeed, the clinical trial's page on clinicaltrials.gov reveals that recruitment is still ongoing for this medical experiment which was first posted in June 2019 and has been updated recently in August 2022. 28 people are sought out from a single site to take part in it."

Answered by AI

Has this experiment previously been conducted?

"Currently, 217 clinical trials pertaining to Olaparib are happening across 1523 cities and 60 countries. This drug was first introduced in a 2005 AstraZeneca-led trial involving 98 patients and successfully completed Phase 1 of the approval process. Subsequently, 204 other experiments have been finalized since then."

Answered by AI

Is this research endeavor still open to new participants?

"Based on recently updated records from clinicaltrials.gov, this experimental trial is presently in search of suitable participants. It was initially published on June 11th 2019 and revised most recently on August 5th 2022."

Answered by AI
~5 spots leftby Mar 2025