Clinical Trials /

AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

NCT02513563

Description:

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.

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer
  • Official Title: A Phase II Trial of AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: MCC-18304
  • NCT ID: NCT02513563

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
CarboplatinParaplatin®Carboplatin/Paclitaxel/AZD1775
PaclitaxelTAXOL®Carboplatin/Paclitaxel/AZD1775
AZD1775MK1775Carboplatin/Paclitaxel/AZD1775

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Carboplatin/Paclitaxel/AZD1775ExperimentalTreatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
  • Carboplatin
  • Paclitaxel
  • AZD1775

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 2 years
Safety Issue:
Description:OS is defined as the duration of time from the date for first treatment (Cycle 1 Day 1) to the date of death.
Measure:Duration of Overall Response (OR)
Time Frame:Up to 2 years
Safety Issue:
Description:The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measure:Duration of Stable Disease (SD)
Time Frame:Up to 2 years
Safety Issue:
Description:Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measure:Disease Control Rates (DCR)
Time Frame:Up to 2 years
Safety Issue:
Description:DCR: Complete Response (CR), Partial Response (PR), and Stable Disease (SD).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • Squamous cell lung cancer

Last Updated

December 13, 2016