Trial Outcomes & Findings for Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer (NCT NCT00003726)

Results Overview

Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

18 months

Results posted on

2016-08-08

Participant Flow

One participant was enrolled to the trial and started on 10mg and increased to 20mg. However developed progression of disease and was removed from the trial.

Funding was pulled and therefore the trial was not completed.

Participant milestones

Participant milestones
Measure	Lepirudin Dose level 1: 10 mg once daily -\> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -\> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -\> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -\> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -\> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -\> (total dose, 50 mg/d)
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lepirudin n=1 Participants Dose level 1: 10 mg once daily -\> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -\> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -\> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -\> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -\> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -\> (total dose, 50 mg/d)
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants
Sex: Female, Male Female	0 Participants n=39 Participants
Sex: Female, Male Male	1 Participants n=39 Participants

PRIMARY outcome

Timeframe: 18 months

Population: No data were collected

Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.

Outcome measures

Outcome data not reported

Adverse Events

Lepirudin

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

James Rigas, MD

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place