Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.

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Detailed Description

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This is a randomised, phase II trial comparing AZD1775 plus pemetrexed and carboplatin followed by maintenance AZD1775 and pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed in patients with previously untreated metastatic non-squamous NSCLC with TP53 mutations. The primary endpoint of the trial is assessment of progression-free survival (PFS).

Conditions

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Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD1775 + carboplatin + pemetrexed

Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.

Group Type EXPERIMENTAL

AZD1775

Intervention Type DRUG

AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies

pemetrexed

Intervention Type DRUG

This drug is a part of a general group of chemotherapy drugs called anti-metabolites. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, this drug helps to stop the growth of cancer cells.

carboplatin

Intervention Type DRUG

This drug is a platinum chemotherapy drug that acts like an alkylating agent. It stops the growth of cancer cells, causing the cells to die.

Placebo + carboplatin + pemetrexed

Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed.

Group Type EXPERIMENTAL

AZD1775 Matching Placebo

Intervention Type DRUG

AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies

pemetrexed

Intervention Type DRUG

This drug is a part of a general group of chemotherapy drugs called anti-metabolites. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, this drug helps to stop the growth of cancer cells.

carboplatin

Intervention Type DRUG

This drug is a platinum chemotherapy drug that acts like an alkylating agent. It stops the growth of cancer cells, causing the cells to die.

Interventions

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AZD1775

AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies

Intervention Type DRUG

AZD1775 Matching Placebo

AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies

Intervention Type DRUG

pemetrexed

This drug is a part of a general group of chemotherapy drugs called anti-metabolites. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, this drug helps to stop the growth of cancer cells.

Intervention Type DRUG

carboplatin

This drug is a platinum chemotherapy drug that acts like an alkylating agent. It stops the growth of cancer cells, causing the cells to die.

Intervention Type DRUG

Other Intervention Names

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MK-1775

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Histologic or cytologic diagnosis of advanced NSCLC, Recurrent or Stage IV disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0).
* No prior chemotherapy for locally advanced or metastatic disease
* Subjects with a known EGFR mutation must have received previous treatment with an EGFR tyrosine kinase inhibitor; and subjects with a known ALK translocation must have received previous treatment with an ALK inhibitor.
* No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
* Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 determination.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
* Absolute neutrophil count (ANC) ≥1500/μL
* Hemoglobin (Hgb) ≥10 g/dL
* Platelets ≥100,000/μL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ≤3.0 x the upper limit of normal (ULN); 5 x ULN if known hepatic metastases
* Total bilirubin ≤1.5 x ULN, unless secondary to Gilbert's disease
* Serum creatinine ≤1.5 x ULN and a calculate creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-Gault method
* Ability to swallow oral medication
* Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops
* Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
* Predicted life expectancy ≥12 weeks
* Must be ≥18 years of age
* Willingness and ability to comply with study and follow-up procedures

Exclusion Criteria

* Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775
* Major surgical procedures ≤28 days of beginning AZD1775, or minor surgical procedures ≤7 days
* Known central nervous system (CNS) disease
* Subject has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates
* Any known hypersensitivity or contraindication to the components of study treatment
* Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (\[NYHA\] Appendix G) ≥ Class 2
* Corrected QT interval (QTc) \>470 msec (as calculated by Fridericia correction formula) at study entry or congenital long QT syndrome.
* Pregnant or lactating
* Any serious, active underlying medical condition that would impair the ability of the subjects to receive study treatment
* Unable or unwilling to take folic acid or vitamin B12
* Presence of other active cancers, or history of treatment for invasive cancer ≤3 years
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No