NCT01590160

Brief Summary

Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos. Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath. Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

6.3 years

First QC Date

April 30, 2012

Last Update Submit

November 8, 2019

Conditions

Lung Cancer - Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose of Ganetespib

    Primary endpoint (phase I): Dose-limiting toxicities during Cycles 1 \& 2; and number of cycles of pemetrexed-cisplatin given. The Phase I trial will consist of three ganetespib dose cohorts, each with 3 or 6 patients: * Cohort 1: 100mg/m2 IV on day 1 and day 15 of each cycle * Cohort 2: 150mg/m2 IV on day 1 and day 15 of each cycle * Cohort 3: 200mg/m2 IV on day 1 and day 15 of each cycle There will be additional patients to be treated with carboplatin (AUC5) instead of cisplatin. If treatment with carboplatin is confirmed to be safe and tolerable, the option of treating patients with either cisplatin or carboplatin during phase II will be taken. The evaluation will be done using an accelerated titrated phase I design. Primary endpoint (phase II): Progression free survival

    6 Months

Secondary Outcomes (1)

  • Progression Free Survival

    24 Months

Study Arms (2)

Cisplatin/Pemetrexed

EXPERIMENTAL

Cisplatin 75mg/m2, Day 1 every 21 days Pemetrexed 500mg/m2, Day 1 every 21 days

Drug: Ganetespib

Carboplatin/Pemetrexed

EXPERIMENTAL

Carboplatin AUC5, Day 1 every 21 days Pemetrexed 500mg/m2, Day 1 every 21 days

Drug: Ganetespib

Interventions

GanetespibDRUG

IV, Using dose from Phase I

Carboplatin/PemetrexedCisplatin/Pemetrexed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathological confirmation of malignant pleural mesothelioma
  • Measurable disease using meso-modified RECIST criteria (CT scan must be within 28 days of registration/randomisation)
  • Performance status ECOG 0-1
  • Age at least 18 years
  • Adequate haematological status:
  • Haemoglobin 100g/L or greater
  • Neutrophil count ≥2.0 x 10\^9/L
  • Platelets ≥100 x 10\^9 /L
  • 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)
  • Chemotherapy naïve
  • Negative serum pregnancy test for female patients of child bearing potential.
  • 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.
  • Ability to understand and willing to sign the written informed consent to participate (including donation of diagnostic biopsy tissue for research)
  • +1 more criteria

You may not qualify if:

  • 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
  • Evidence of CNS metastases that in the opinion of the investigator should receive local treatment prior to systemic cytotoxic chemotherapy
  • 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
  • Serum potassium, magnesium, and calcium levels no more than 10% outside the Sites normal reference ranges
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Cancer Trials Centre

London, W1T 4TJ, United Kingdom

Location

Related Publications (1)

  • Fennell DA, Danson S, Woll PJ, Forster M, Talbot D, Child J, Farrelly L, Sharkey A, Busacca S, Ngai Y, Hackshaw A, Wheeler GM. Ganetespib in Combination with Pemetrexed-Platinum Chemotherapy in Patients with Pleural Mesothelioma (MESO-02): A Phase Ib Trial. Clin Cancer Res. 2020 Sep 15;26(18):4748-4755. doi: 10.1158/1078-0432.CCR-20-1306. Epub 2020 Jul 15.

    PMID: 32669375DERIVED

MeSH Terms

Interventions

STA 9090

Study Officials

  • Professor D Fennell, MBBS

    University of Leicester & Leicester University Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

August 1, 2013

Primary Completion

November 5, 2019

Study Completion

November 5, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

GB(1)