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PARP Inhibitor
Olaparib + Vitamin C for Prostate Cancer
Phase 2
Recruiting
Led By Channing Paller, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have ECOG performance status 0-1
Must have progressed on specified lines of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat prostate cancer that has progressed despite hormonal therapy. The primary endpoint is PSA50 response, defined as a 50% reduction in PSA from baseline.
Who is the study for?
Men over 18 with castration-resistant prostate cancer, who have progressed after one systemic treatment. They must have a PSA of at least 1 ng/mL, good performance status (able to carry out daily activities), and normal organ/marrow function. Contraception is required for men and their partners. Exclusions include prior PARP inhibitors use, recent major surgery or chemotherapy, strong CYP3A inducers use, uncontrolled heart conditions, active hepatitis or HIV.Check my eligibility
What is being tested?
The trial tests the combination of Olaparib (a PARP inhibitor) and high-dose IV Vitamin C in treating prostate cancer without DNA repair gene mutations. It measures the reduction in PSA levels by half from baseline as the main outcome and looks at safety through incidence of severe toxicities.See study design
What are the potential side effects?
Possible side effects may include nausea, fatigue, anemia (low red blood cell counts), potential kidney issues due to creatinine levels changes; allergic reactions are possible given it's a drug study but specific side effects will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My condition worsened despite treatment.
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I am 18 years old or older.
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My organs and bone marrow are functioning normally.
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I am on ongoing hormone therapy with low testosterone levels.
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My prostate cancer is spreading despite low testosterone levels.
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I have been diagnosed with prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA50 response
Secondary outcome measures
Overall survival of patients with mCRPC receiving olaparib in combination with IV ascorbic acid
PSA doubling time in patients with mCRPC receiving olaparib in combination with IV ascorbic acid
PSA progression free survival (PSA PFS) of patients with mCRPC receiving olaparib in combination with IV ascorbic acid
+2 moreSide 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
1Treatment groups
Experimental Treatment
Group I: Olaparib and Vitamin CExperimental Treatment2 Interventions
Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Vitamin C
2017
Completed Phase 4
~18470
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,885 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,333 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,227 Total Patients Enrolled
59 Trials studying Prostate Cancer
27,507 Patients Enrolled for Prostate Cancer
McGuff Pharmaceuticals, Inc.Industry Sponsor
3 Previous Clinical Trials
128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a mutation in my DNA repair genes.I have cancer that has spread to my brain or spinal cord.I have lasting side effects from past cancer treatments.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I am fully active or can carry out light work.I have a serious illness that is not under control.My condition worsened despite treatment.I am 18 years old or older.I had major surgery less than 2 weeks before starting the trial medication.I had radiation or biological cancer therapy within the last 2 weeks.I have used certain medications in the last 6 months.I have a serious heart condition.I have active hepatitis.I agree to use effective contraception if I can father a child.My partner uses effective birth control methods.I am on ongoing hormone therapy with low testosterone levels.My prostate cancer is spreading despite low testosterone levels.I have undergone several treatments for my condition.I can take pills and am open to getting a port for ascorbate treatment.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I have serious health conditions that make my medical risk high.I cannot swallow pills or have stomach issues affecting medication absorption.I have been diagnosed with prostate cancer.I will likely need chemotherapy or radiation for pain relief soon.I have had a bone marrow or double cord blood transplant.I have brain metastases that are causing symptoms and are not under control.I had another cancer but was treated successfully over 5 years ago with no signs of it returning.I have never taken olaparib, rucaparib, or any PARP inhibitor.My organs and bone marrow are functioning normally.I am currently taking medication for bone health.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib and Vitamin C
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.
Are there any openings remaining for this experimental protocol?
"The study as detailed on clinicaltrials.gov does not appear to be accepting participants at this time; the trial was originally posted in December 2022 and last modified in October 2022. However, there are still 1,324 other trials that may welcome potential candidates."
Answered by AI
To what degree could Olaparib be a risk factor to patients?
"Olaparib's safety score is 2, as there are a handful of studies indicating its basic security but none that confirm it can treat the condition."
Answered by AI
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