Parp Inhibitor in Advanced Non-Small Cell Lung Cancer (PIN)

Sponsor
Lisette Nixon
Study ID
NCT01788332
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib is a potent inhibitor of poly (ADP-ribose) polymerase enzyme (PARP), (molecular weight 434) that is being developed as a monotherapy as well as for combination with chemotherapy and other anti-cancer agents. Olaparib can lead to tumour regression in patients with DNA repair deficient NSCLC. Olaparib may also enhance the DNA damaging effects of chemotherapy.
  • Placebo — OTHER
    3 100mg tablets to be administered twice a day with approximately 240ml of water

Study Details

In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients with NSCLC but those treated will still only live for an average of 9 or 10 months after diagnosis. The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC tumours that respond to chemotherapy are less able to repair this damage. This can be exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of mutation in two or more genes leads to cell death. Up to 300 patients who are to receive standard chemotherapy treatment will be initially registered into the trial. Of these patients, 114 patients who have responded to chemotherapy will be randomly allocated to receive either Olaparib or an inactive dummy pill or placebo by mouth. The trial will assess whether Olaparib delays disease progression following standard chemotherapy treatment in patients. It will also show whether the side effects of adding Olaparib following standard treatment are acceptable.

Key Dates

Start date
Jan 31, 2014
Status verified
Oct 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Olaparib
    3 100mg tablets to be administered twice a day with approximately 240ml of water.
  • Placebo Comparator: Placebo
    3 100mg tablets to be administered twice a day with approximately 240ml of water.

Primary Outcome Measure

Progression-free survival [ Time Frame: 72 weeks ]

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