AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:September 8, 2015
End Date:October 2020

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A Phase II Trial of AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

The purpose of this study is to find out what effects (good and bad) AZD1775 used in
combination with carboplatin and paclitaxel will have on participants and their cancer.


Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures

- Histologic or cytological diagnosis of Squamous Cell Lung Cancer (SQCLC) with
advanced/metastatic stage, with no known curative treatment options. Prior
platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given
for locally advanced disease is considered first line therapy only if recurrent (local
or metastatic) disease developed within 6 months of completing therapy. Potential
participants with recurrent disease > 6 months will be eligible.

- Female or male aged >/= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of 0/1

- Prior chemotherapy in the adjuvant setting is allowed

- Prior radiotherapy is allowed

- Prior Immunotherapy with PD1i, PDL1i, anti-CTLA -4 or vaccines is allowed

- Must have normal organ and marrow function

- Have archival tissue available or undergo a fresh biopsy where clinically feasible
after discussion with the sponsor

- Women of childbearing potential and men must agree to use adequate contraception prior
to study entry and for the duration of study participation and women who are breast
feeding are excluded from the study. Both women and men should be fully informed of
the lack of reproductive toxicity testing, and women must have a negative pregnancy
test prior to enrolment.

Exclusion Criteria:

- Progressive, symptomatic untreated brain metastases

- Pregnancy or breast feeding

- A serious uncontrolled medical disorder or active infection that in the investigator's
opinion would impair the participant's ability to receive study treatment

- Prior use of platinum or paclitaxel for stage IV Non-small Cell Lung Cancer (NSCLC) or
concurrent use of other anticancer approved or investigational agents

- Known Hepatitis B or C or HIV infection

- Second primary malignancy, other than in situ malignancies or adequately treated basal
cell carcinoma of the skin or other malignancy treated at least 2 years previously
with no evidence of recurrence

- Have had prescription or non-prescription drugs or other products (i.e., grapefruit
juice) known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow
therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4, which
cannot be discontinued 2 weeks before Day 1 of dosing and withheld throughout the
study until 2 weeks after the last dose of study drug

- Co-administration of aprepitant and fosaprepitant during this study is prohibited

- AZD1775 is an inhibitor of breast cancer resistance protein (BCRP). The use of statins
including Atorvastatin which are substrates for BCRP are therefore prohibited and
patients should be moved on to non-BCRP alternatives.

- Herbal preparations are not allowed throughout the study. These herbal medications
include, but are not limited to: St. John's wort, kava, ephedra (ma huang), gingko
biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jhanelle Gray, M.D.
Phone: 813-745-6636
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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