Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01590160 : Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Histopathological confirmation of malignant pleural mesothelioma

2. Measurable disease using meso-modified RECIST criteria (CT scan must be within 28
days of registration/randomisation)

3. Performance status ECOG 0-1

4. Age at least 18 years

5. Adequate haematological status:

- Haemoglobin 100g/L or greater

- Neutrophil count ?2.0 x 10^9/L

- Platelets ?100 x 10^9 /L

6. Adequate organ function:

- Bilirubin ?1.5x ULN, ALP ?2.5x ULN, ALT or AST ?1.5x ULN

- Serum creatinine ?1.5 x ULN or calculated creatinine clearance ? 60ml/min (C&G
or EDTA)

7. Chemotherapy naïve

8. Negative serum pregnancy test for female patients of child bearing potential.

9. Male subjects and women of child bearing potential must agree to use an acceptable
method of birth control for the duration of the trial and for 6 months after the last
trial treatment cycle has finished.

10. Ability to understand and willing to sign the written informed consent to participate
(including donation of diagnostic biopsy tissue for research)

11. Ability to comply with the requirements of the protocol

Exclusion Criteria:

1. Prior exposure to other investigational or commercial agents or therapies
administered with the intent of treating the patient's malignancy. This includes
crizotinib, other ALK-targeted agents, and any Hsp90 inhibitor (e.g. ganetespib).
Prior valproic acid is acceptable but only if there has been at least 30 days
wash-out period

2. Evidence of CNS metastases that in the opinion of the investigator should receive
local treatment prior to systemic cytotoxic chemotherapy

3. Uncontrolled intercurrent illness including but not limited to:

- Symptomatic neurological illness

- Active uncontrolled systemic infection considered opportunistic, life
threatening or clinically significant at the time of treatment

- Significant pulmonary disease or hypoxia

- Psychiatric illness/social situations that would limit compliance with trial
requirements

- Human immunodeficiency virus (HIV)-positive patients

- Known hepatitis B or C infection

- Uncontrolled diabetes mellitus

4. Serum potassium, magnesium, and calcium levels no more than 10% outside the Sites
normal reference ranges

5. Known serious cardiac illness including but not confined to:

- Clinically unstable cardiac disease, including unstable atrial fibrillation,
symptomatic bradycardia, unstable congestive heart failure, active myocardial
ischemia, or indwelling temporary pacemaker

- Ventricular tachycardia or a supraventricular tachycardia that requires
treatment with a Class Ia anti-arrhythmic drug (e.g., quinidine, procainamide,
disopyramide) or Class III anti-arrhythmic drug (e.g., sotalol, amiodarone,
dofetilide). Use of other anti-arrhythmic drugs is permitted.

- Use of medications that have been linked to the occurrence of torsades de
pointes

- Second- or third-degree atrioventricular (AV) block unless treated with a
permanent pacemaker

- Complete left bundle branch block (LBBB)

- History of long QT Syndrome or a family member with this condition

- QTc >470ms (average of triplicate ECG recordings); a consistent method of QTc
calculation must be used for each patient's QTc measurements. QTcF (Fridericia's
formula) is preferred

6. The patient has a history of prior malignant tumour, unless the patient has been
without evidence of disease for at least three years, or the tumour was a
non-melanoma skin tumour or in situ cervix carcinoma

7. Pregnant women or those who are lactating

8. Pre-planned surgery or procedures that would interfere with the conduct of the trial

9. Patients who have had surgery (does not include pleurodesis or pleurectomy) within 28
days of randomisation should not be included

10. Previous treatment of mesothelioma with systemic chemotherapy

11. Receipt of extensive radiation therapy, systemic chemotherapy, or other
anti-neoplastic therapy within 4 weeks before enrolment is not allowed. However,
drain site radiotherapy is allowed

12. Significant weight loss (?10% body weight) within the 4 weeks prior to Cycle 1 Day 1.

13. Patients who have had a yellow fever vaccination in the previous 30 days.

14. Other medications, severe acute/chronic medical or psychiatric condition, or
laboratory abnormality that may increase the risk associated with study participation
or study drug administration, or may interfere with the interpretation of study
results, and in the judgment of the investigator would make the subject inappropriate
for entry into this study.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01590160      |      Link to official Clinicaltrials.gov listing
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