A Pilot Study of a Steroid Sulphatase Inhibitor(BN83495) in Patients Receiving an Oral EpidermalGrowth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI) for the Treatment of Non-Small Cell LungCancer (NSCLC)

Phase 1

Completed

• Conditions: on-Small Cell Lung Cancer; Skin Rash; Non-Small Cell Lung Cancer; Cancer - Lung - Non small cell; Skin - Dermatological conditions

• Registration Number: ACTRN12610001073099
• Lead Sponsor: Professor John Zalcberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with histologically documented, unresectable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC who are otherwise eligible for treatment with an EGFR-TKI (erlotinib or gefitinib), or who are already receiving an EGFR-TKI.
2. Patients who are scheduled to receive, or are already receiving a standard dose EGFR-TKI.
3. The presence of any EGFR-TKI -related rash in patients already on treatment must be grade 2 or less.
4. Male or female patients aged 18 years or over who weigh 40kg or more.
5. ECOG performance status of 0 – 2, inclusive.
6. Granulocyte count =1.5 x 109/L and platelet count >100 x 109/L.
7. Serum bilirubin must be =1.5 x upper limit of normal (ULN). ALT must be = 2 x ULN.
8. Serum creatinine =1.5 ULN or creatinine clearance =60 ml/min.
9. Able to comply with study and follow-up procedures. Patients must be willing to be photographed.
10. a) Female patient of childbearing potential must have a negative pregnanacy test within one week prior to study entry OR have been amenorrhoeic for at least two years.
b) All patients of reproductive potential must agree to use birth control for the duration of the study. This is only required for as long as the patient has reproductive potential. The type of birth control is a decision which should be made between the treating physician and the patient.
11. Patient has given written, informed consent to participate in the study.

Exclusion Criteria

1. Patients who cannot take oral medication.
2. Patients with prior prostate, breast or endometrial cancer unless in remission for = 5 years.
3. Patients receiving other hormonally active agents.
4. Pregnancy or lactation.
5. Concurrent or recent history (within the last 3 months) of significant skin disease, not related to EGFR-TKI therapy.
6. Concurrent use of systemic or topical glucocorticoids (apart from intranasal and inhaled corticosteroids to treat rhinitis and asthma, respectively), for patients starting both an EGFR-TKI and BN83495. Patients already receiving an EGFR-TKI and topical glucocorticoids as part of their management are allowed.
7. Concurrent use of systemic carbonic anhydrase II inhibitors (e.g.acetazolamide, dichlorphenamide,methazolamide)
8. Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
9. Patients unwilling or unable to comply with protocol and patients with a history of non-compliance or inability to grant informed consent.
10. Current participation in another clinical trial using an investigational agent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency and grade of papulo-pustular rash in patients with non-small cell lung cancer (NSCLC) receiving an EGFR-TKI and BN83495.<br><br>To be assessed by medical review and photographs of the patient's skin - and graded based on CTC criteria.[After 12 weeks of treatment];The frequency and grade of additional cutaneous (side) effects in patients with NSCLC receiving an EGFR-TKI and BN83495.<br><br>To be assessed by medical review and grading based on CTC criteria - cutaneous side effects that are commonly experienced by patients on EGFR-TKIs eg. paronychia, trichomegaly, dry skin, hair thinning, skin cracks.[After 12 weeks of treatment]

Secondary Outcome Measures

Name	Time	Method
The side effect profile of the combination (BN83495 + an EGFR-TKI).<br><br>To be assessed by medical review and grading based on CTC criteria.[After 12 weeks of treatment];Changes in oestrogen, androgen-related biochemistry and EGFR-TKI blood levels associated with the combination (BN83495 + EGFR-TKI).[After 12 weeks of treatment]