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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

Eastern Cooperative Oncology Group performance status of 0 or 1

Must not have

Major surgery within 4 weeks of starting the study treatment

Any severe and/or uncontrolled medical conditions or other conditions that could affect study participation, such as severely impaired lung function; any active (acute or chronic) or uncontrolled infection/disorders; or non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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 fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks.

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I do not have any severe health issues that could interfere with the study.

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I cannot take pills by mouth or have stomach issues that affect medication absorption.

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I have severe heart issues or chest pain.

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I have a serious heart rhythm problem or had a recent heart attack.

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I am allergic to olaparib, vorinostat, or similar medications.

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I have lung inflammation or am at risk for it.

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I do not have uncontrolled brain cancer spread.

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I have had a bone marrow or double cord blood transplant.

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I am not taking strong or moderate drugs that affect liver enzymes.

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I have lasting side effects from cancer treatment, but not hair loss.

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I do not have an active infection and am not known to be HIV positive.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

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I am not taking any strong or moderate drugs that affect liver enzymes.

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I have a history of liver disease, like cirrhosis or hepatitis B/C.

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I have never been treated with PARP or HDAC inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD

Secondary study objectives

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%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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. . Patients who derive clinical benefit (CR, PR, or SD) after 4 cycles of treatment can continue to receive the study treatment until they experience unacceptable AEs or disease progression. 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

0 / 18Eligibility criteria met