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A Phase I Dose Escalation Study of the HIV Protease Inhibitor, Nelfinavir, Given Concomitantly With Radical Radiotherapy (RT) for the Treatment of Non-Small Cell Lung Cancer (NSCLC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I Dose Escalation Study of the HIV Protease Inhibitor, Nelfinavir, Given Concomitantly With Radical Radiotherapy (RT) for the Treatment of Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Histologically confirmed NSCLC except bronchoalveolar cancer

- Patients deemed suitable for radical RT according to local policy

- TNM stage T1-2, N0-1, M0 plus patients with local recurrence

- Adequate lung function as defined by protocol

- Age ≥ 18 years

- ECOG performance status 0-2

- Written informed consent

- Patient able and willing to comply with all protocol requirements

Exclusion Criteria:

- History of other active invasive malignancy (excluding non-melanoma skin cancer and
in situ carcinoma of the cervix), where the extent of disease or treatment for that
condition may interfere with the study endpoints

- Previous RT to the chest

- Chemotherapy, immunotherapies or investigational medicinal products within 4 weeks of
the start of nelfinavir treatment. Ie any neoadjuvant treatment must be completed 4
weeks prior.

- Liver impairment (serum bilirubin ≥ 2 times upper limit of normal, serum AST ≥ 2
times the upper limit of normal)

- Pregnant or breast-feeding women or women of childbearing potential unless effective
methods of contraception are used. Contraceptives that contain norethisterone or
ethinylestradiol must be replaced by other contraceptive measures

- Concurrent use of contraindicated drugs that cannot be substituted or discontinued 2
weeks or more prior to the start of trial treatment

- Known hypersensitivity to nelfinavir or any of its excipients

- Other psychological, social or medical condition, physical examination finding or a
laboratory abnormality that the Investigator considers would make the patient a poor
trial candidate or could interfere with protocol compliance or the interpretation of
trial results

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Description:

To establish the maximum tolerated dose of nelfinavir in combination with radical radiotherapy for patients with non-small cell lung cancer

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Katherine Vallis

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oxford and Oxford Radcliffe NHS Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

EP-TSC-651

NCT ID:

NCT01447589

Start Date:

February 2012

Completion Date:

October 2012

Related Keywords:

  • Lung Cancer
  • Radiosensitiser
  • Lung Neoplasms

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