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PARP Inhibitor

Olaparib + Temozolomide for Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Anna Farago, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of measurable disease (RECIST 1.1): At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
Participant must have histologically or cytologically confirmed small cell lung cancer and may not be a candidate for potentially curative therapy.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is studying if olaparib and temozolomide may work better in treating patients with small cell lung cancer.

Eligible Conditions
  • Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years 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 of Olaparib and Temozolomide
Overall Response Rate for Olaparib and Temozolomide
Secondary outcome measures
Methylation promoter methylation status
Overall Survival
PAR levels
+2 more

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%
Dyspnoea
11%
Alanine aminotransferase increased
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Thrombocytopenia
9%
Dizziness
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
9%
Aspartate aminotransferase increased
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%
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%
Bladder papilloma
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

Awards & Highlights

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 TemozolomideExperimental Treatment2 Interventions
- Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Once the MTD is determined, the study will move to the phase II portion. Olaparib- Oral, on determined days per cycle Temozolomide- Oral, on determined days per cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~1270
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,862 Previous Clinical Trials
13,148,998 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,178 Previous Clinical Trials
289,626,923 Total Patients Enrolled
Zofia PiotrowskaLead Sponsor

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02446704 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Olaparib and Temozolomide
Small Cell Lung Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT02446704 — Phase 1 & 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02446704 — Phase 1 & 2

Frequently Asked Questions

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

What is Olaparib's most popular therapeutic use?

"Olaparib is often used to treat patients with advance directives. Olaparib can also help those who have undergone previous chemotherapy, experienced disease progression, or received nitrosourea treatment."

Answered by AI

How many people are in this clinical trial?

"Unfortunately, this study is not admitting any more participants at the moment. The trial was first posted on October 13th, 2015 and updated January 24th, 2022. If you are interested in other studies, 1617 trials for small cell lung cancer (sclc) and 407 Olaparib studies are currently looking for patients."

Answered by AI

Could you please provide a history of Olaparib clinical trials?

"There are 407 active clinical trials for Olaparib worldwide, with 52 of those in Phase 3. Most studies are located in Phoenix, Arizona; however, there are 13942 total locations running these trials."

Answered by AI

Is this research the first to explore this treatment method?

"There are currently 407 ongoing trials for Olaparib in 59 different countries. The first trial was conducted 18 years ago by Schering-Plough and completed its Phase 2 drug approval stage with the help of 60 patients. Since then, 359 more studies have been completed."

Answered by AI

Are you currently looking for participants in this trial?

"This clinical trial is no longer recruiting patients. It was originally posted on 10/13/2015 and the last edit was made on 1/24/2022. If you are looking for other trials, there are currently 1617 active clinical trials enrolling patients with small cell lung cancer (sclc) and 407 Olaparib trials actively recruiting participants."

Answered by AI
~7 spots leftby Dec 2024