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A Randomized Phase II Study of SUBATM-itraconazole in Patients With Untreated Squamous NSCLC. (NA_00067809)

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ClinicalTrials.gov Identifier: NCT01752023
Recruitment Status : Terminated (Low Accrual)
First Posted : December 18, 2012
Results First Posted : June 2, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer Metastatic
Interventions Drug: Cisplatin + Gemcitabine with SUBATM-itraconazole
Drug: Cisplatin + Gemcitabine
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cisplatin + Gemcitabine With SUBATM-itraconazole Cisplatin + Gemcitabine
Hide Arm/Group Description

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Period Title: Overall Study
Started 2 1
Completed 0 0
Not Completed 2 1
Reason Not Completed
Physician Decision             2             1
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
0
   0.0%
1
  33.3%
>=65 years
1
  50.0%
1
 100.0%
2
  66.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
59
(52 to 66)
67
(67 to 67)
66
(52 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
1
  50.0%
0
   0.0%
1
  33.3%
Male
1
  50.0%
1
 100.0%
2
  66.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2
 100.0%
1
 100.0%
3
 100.0%
1.Primary Outcome
Title Objective Response Rates
Hide Description Per response evaluation criteria in solid tumors criteria
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Trial closed due to early stopping rule, patients were not analyzed as there were only 3 patients enrolled.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Tumor Blood Flow.
Hide Description To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.
Time Frame 6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.
Arm/Group Title Cisplatin + Gemcitabine With SUBATM-itraconazole Cisplatin + Gemcitabine
Hide Arm/Group Description:

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Time to Progression
Hide Description To determine the median time to progression and median duration of survival of patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.
Time Frame 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.
Arm/Group Title Cisplatin + Gemcitabine With SUBATM-itraconazole Cisplatin + Gemcitabine
Hide Arm/Group Description:

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Cisplatin + Gemcitabine with SUBATM-itraconazole: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Cisplatin + Gemcitabine: Active Comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Adverse Effects
Hide Description To characterize the adverse effects of cisplatin and gemcitabine with or without SUBATM-itraconazole in this patient population.
Time Frame 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.
Arm/Group Title Cisplatin + Gemcitabine With SUBATM-itraconazole Cisplatin + Gemcitabine
Hide Arm/Group Description:

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Itraconazole Exposure Parameters
Hide Description To correlate itraconazole exposure parameters with median time to progression and median survival in this patient population.
Time Frame 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.
Arm/Group Title Cisplatin + Gemcitabine With SUBATM-itraconazole Cisplatin + Gemcitabine
Hide Arm/Group Description:

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Tumor Necrosis
Hide Description To assess changes in tumor necrosis in response to cisplatin and gemcitabine with or without SUBATM-itraconazole.
Time Frame 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.
Arm/Group Title Cisplatin + Gemcitabine With SUBATM-itraconazole Cisplatin + Gemcitabine
Hide Arm/Group Description:

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description

SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.

Arm A: Experimental Arm

Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Arm B: Active Comparator

All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ronan Kelly, MD
Organization: SKCCC at Johns Hopkins
Phone: 443-287-0005
EMail: rkelly25@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01752023     History of Changes
Other Study ID Numbers: J1230
NA_00067809 ( Other Identifier: JHMIRB )
First Submitted: December 14, 2012
First Posted: December 18, 2012
Results First Submitted: March 6, 2017
Results First Posted: June 2, 2017
Last Update Posted: October 17, 2018