Trial Outcomes & Findings for Malignant Pleural Effusion With ZD6474 (NCT NCT00402896)

Last Updated: 2016-03-09

Results Overview

Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks

Results posted on

2016-03-09

Participant Flow

Recruitment Period: October 2006 to July 2010 at UT MD Anderson Cancer Center included NSCLC participants diagnosed with proven metastatic disease to the pleural space by pleural fluid cytology or pleural biopsy and required IPC placement because of symptomatic recurrent pleural effusions between May 2007 and February 2010.

The clinical trial was terminated before reaching the target patient accrual due to ZD6474 unavailability and of the 28 enrolled but only 20 received treatment. Slow accrual was a contributing factor to early termination.

Participant milestones

Participant milestones
Measure	ZD6474 300 mg/day orally for 10 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Malignant Pleural Effusion With ZD6474

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZD6474 n=20 Participants 300 mg/day orally for 10 weeks.
Age, Continuous	72 years n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

PRIMARY outcome

Timeframe: Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks

Population: Twenty eligible participants were analyzed for the primary outcome in the trial, eleven completed 10 weeks of treatment. All twenty participants completed the study.

Outcome measures

Outcome measures
Measure	ZD6474 n=20 Participants 300 mg/day orally for 10 weeks.
Median Time to Pleurodesis	35 Days Interval 15.0 to Distributional assumptions were not available making it not possible to obtain an exact 95% confidence interval for the median.

Adverse Events

ZD6474

Serious events: 12 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ZD6474 n=20 participants at risk 300 mg/day orally for 10 weeks.
Nervous system disorders CNS Ischemia	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Renal and urinary disorders Creatinine	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Cardiac disorders Atrial Fibrillation	10.0% 2/20 • Number of events 2 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Hypoxia	15.0% 3/20 • Number of events 3 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.0% 3/20 • Number of events 3 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
General disorders Pain	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Nervous system disorders Motor Neuropathy	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Dehydration	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Pneumonia	15.0% 3/20 • Number of events 3 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
General disorders Weight Loss	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Left Pleural Effusion	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Infections and infestations R. Pneumothorax	10.0% 2/20 • Number of events 2 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Metabolism and nutrition disorders Hyponatremia	10.0% 2/20 • Number of events 2 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.

Other adverse events

Other adverse events
Measure	ZD6474 n=20 participants at risk 300 mg/day orally for 10 weeks.
Blood and lymphatic system disorders Anemia	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 2/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Prolonged PTT	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
General disorders Fatigue	35.0% 7/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
General disorders Weight loss	25.0% 5/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Anorexia	10.0% 2/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Nausea	15.0% 3/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Diarrhea	60.0% 12/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Constipation	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Xerostomia	10.0% 2/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Gastrointestinal disorders Abdominal Distension/bloating	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Musculoskeletal and connective tissue disorders Muscle weakness	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Cardiac disorders Prolonged QTc	25.0% 5/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Cardiac disorders Cardiac arrhythmia	15.0% 3/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Cardiac disorders Palpitations	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Cardiac disorders Hypertension	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Cardiac disorders Premature ventricular contractions	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Skin and subcutaneous tissue disorders Acne	10.0% 2/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Skin and subcutaneous tissue disorders Erythema multiforme	20.0% 4/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Skin and subcutaneous tissue disorders Rash/desquamation	20.0% 4/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
General disorders Sweating	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 2/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Infections and infestations Infection with normal ANC	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Hypomagnesemia	25.0% 5/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Hypokalemia	20.0% 4/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Hyponatremia	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Hypophosphatemia	15.0% 3/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Blood and lymphatic system disorders Hyperkalemia	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.
Nervous system disorders Dizziness	5.0% 1/20 • Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.

Additional Information

Carlos A. Jimenez, MD/Professor, Pulmonary Medicine

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place