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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Thrombocytopenia

Dizziness

Hyperglycaemia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Aspartate aminotransferase increased

Blood creatinine increased

Weight decreased

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Dysgeusia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

General physical health deterioration

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Bladder papilloma

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

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

0 / 11Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy

Zofia Piotrowska 2015. "Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02446704.

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