Olaparib Dose Escalating Trial + Concurrent RT With or Without Cisplatin in Locally Advanced NSCLC

Sponsor
The Netherlands Cancer Institute
Study ID
NCT01562210
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib will be given orally BID for 36 days, administrated with a 12 hour interval. Olaparib will start 2 days before RT and will continue for 2 days after the last RT fraction. Olaparib is also given during the non-radiotherapy days but no maintenance treatment is given after radiotherapy is finished. The first cohort will receive Olaparib with a dose of 25mg BID combined with Cisplatin and RT. Thereafter in both with and without cisplatin arms dose escalation will follow to 50mg, 100mg, 200mg, 300mg and 400mg BID.
  • Cisplatin — DRUG
    6 mg/m2 (5 days/week), 1-1.5 hr before the irradiation (week 1 to 5), given as a 5-minutes intravenous infusion.
  • Radiation — RADIATION
    A total dose of 66 Gy will be given in 24 fractions from week 1 to 5, excluding the weekends.

Study Details

Phase I dose escalating trial. Primary objective of this study is to define the maximal tolerated dose (MTD)of Olaparib in combination with high dose radiotherapy with or without daily dose Cisplatin in locally advanced NSCLC. Secondary objectives include to define safety profile, determine PK/Pd variables and document preliminary evidence of objective tumor response.

Key Dates

Start date
Apr 30, 2012
Status verified
Mar 2020
Primary completion
May 31, 2019
Completion
Mar 13, 2020

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib, radiation +/- Cisplatin
    Olaparib and radiotherapy with or without Cisplatin

Primary Outcome Measure

The incidence of dose limiting toxicities (DLTs) [ Time Frame: from start until 3 months after the last RT day ]

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