Trial Outcomes & Findings for A Randomized Phase II Study of SUBATM-itraconazole in Patients With Untreated Squamous NSCLC. (NCT NCT01752023)

NCT ID: NCT01752023

Last Updated: 2018-10-17

Results Overview

Per response evaluation criteria in solid tumors criteria

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2018-10-17

Participant Flow

Participant milestones

Measure	Cisplatin + Gemcitabine With SUBATM-itraconazole 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	Cisplatin + Gemcitabine 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 Study STARTED	2	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Cisplatin + Gemcitabine With SUBATM-itraconazole 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	Cisplatin + Gemcitabine 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 Study Physician Decision	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm A n=2 Participants 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 n=1 Participants 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 n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	59 years n=93 Participants	67 years n=4 Participants	66 years n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Trial closed due to early stopping rule, patients were not analyzed as there were only 3 patients enrolled.

Per response evaluation criteria in solid tumors criteria

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 weeks.

Population: Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years.

Population: Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years.

Population: Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.

To characterize the adverse effects of cisplatin and gemcitabine with or without SUBATM-itraconazole in this patient population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years.

Population: Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.

To correlate itraconazole exposure parameters with median time to progression and median survival in this patient population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years.

Population: Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.

To assess changes in tumor necrosis in response to cisplatin and gemcitabine with or without SUBATM-itraconazole.

Outcome measures

Outcome data not reported

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronan Kelly, MD

SKCCC at Johns Hopkins

Phone: 443-287-0005

Email: rkelly25@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place