AZD2014 and Weekly Paclitaxel in Squamous NSCLC

Study identifier:D2274C00001

ClinicalTrials.gov identifier:NCT02403895

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase 2a, Multi-centre, Single-arm Trial of the Combination of AZD2014 and Weekly Paclitaxel in Patients with Relapsed or Refractory Squamous Non-Small Cell Lung Cancer After At Least One Line of Prior Therapy

Medical condition

squamous non small cell lung cancer

Phase

Phase 2

Healthy volunteers

Study drug

Open-label AZD2014, paclitaxel

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 15 Apr 2015

Primary Completion Date: 29 Dec 2016

Study Completion Date: 29 Dec 2016

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1.Histologically or cytologically proven squamous non-small cell lung cancer (NSCLC) where treatment with weekly paclitaxel is an appropriate treatment option.
2.Relapsed or refractory disease after at least one line of prior therapy. Subjects must have previously received appropriate line(s) of standard of care (SOC) treatment.
3.Measurable disease by RECIST v1.1 criteria
4.Life expectancy of at least 12 weeks.
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

1.Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and Mitomycin-C) before treatment.
2.Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities which, in the opinion of the Investigator, should not exclude the patient.
3.Known leptomeningeal involvement, brain metastases or spinal cord compression.
4.History of hypersensitivity (> Grade 2) to active or inactive excipients of AZD2014, drugs containing Cremophor, taxanes or structurally/chemically similar drugs
5.Current refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014
6.Patients with Diabetes Type I or uncontrolled Type II (HbA1c > 59 mmol/mol assessed locally) as judged by the Investigator
7.Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered
8. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as:
• Absolute neutrophil count 1500 cells/mm3 (1.5 x 109/L)
• Platelet count 100.000 cells/mm3 (100 x 109/L)
• Haemoglobin 9.0 g/dL
9. Adequate hepatic and renal function defined as:
• Serum aspartate transaminase (AST) or alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or 5 x ULN in the presence of liver metastases
• Alkaline phosphatase (ALP) < 5 x ULN
• Serum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
• Estimated Creatinine Clearance 50 ml/min (Cockcroft-Gault) or serum creatinine 1.5 x ULN

No locations available

Arms	Assigned Interventions
Experimental: Open-label AZD2014 Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel	Drug: Open-label AZD2014 Dual TORC1/TORC2 inhibitor Drug: paclitaxel Taxane

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Chandra P Belani

Hershey Medical Center