Trial Outcomes & Findings for PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer (NCT NCT00544674)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

From registration until disease progression/recurrence

Results posted on

2012-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	PR104 Subjects will receive 1100 mg/m\^2 PR-104 intravenously once every 21 days (one cycle). In addition, subjects will undergo positron emission topography (PET) imaging with F-18-Fluoro Misonidazole (FMISO) for the assessment of hypoxia and with F-18-Fluorodeoxyglucose (FDG) for the assessment of glucose metabolism.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PR104 n=5 Participants 1100 mg/m\^2 PR104 by IV over one hour every three weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	63 years STANDARD_DEVIATION 9.19 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: From registration until disease progression/recurrence

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days following the last administration of study treatment

The number of participants with at least one Serious Adverse Event was measured.

Outcome measures

Outcome measures
Measure	PR104 n=4 Participants 1100 mg/m\^2 PR104 by IV over one hour every three weeks
Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events	2 participants

SECONDARY outcome

Timeframe: Every 3 months for 2 years after discontinuation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy

Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration of the first subject until radiological progression or recurrence whichever came first

Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 and 2 of Cycles 1 and 4

Outcome measures

Outcome data not reported

Adverse Events

PR104

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PR104 n=4 participants at risk 1100 mg/m\^2 PR104 by IV over one hour every three weeks
Gastrointestinal disorders Vomiting	25.0% 1/4
Metabolism and nutrition disorders Dehydration	25.0% 1/4

Other adverse events

Other adverse events
Measure	PR104 n=4 participants at risk 1100 mg/m\^2 PR104 by IV over one hour every three weeks
General disorders Fatigue	50.0% 2/4
General disorders Chest pain	25.0% 1/4
Blood and lymphatic system disorders Anaemia	50.0% 2/4
Blood and lymphatic system disorders Neutropenia	50.0% 2/4
Blood and lymphatic system disorders Thrombocytopenia	50.0% 2/4
Blood and lymphatic system disorders Leukopenia	25.0% 1/4
Blood and lymphatic system disorders Pancytopenia	25.0% 1/4
Ear and labyrinth disorders Tinnitus	25.0% 1/4
Gastrointestinal disorders Nausea	25.0% 1/4
Infections and infestations Pneumonia	25.0% 1/4
Investigations Weight decreased	25.0% 1/4
Nervous system disorders Dizziness	25.0% 1/4
Nervous system disorders Dysgeusia	25.0% 1/4

Additional Information

Director of Clinical Development

Proacta, Inc.

Phone: 858-642-0386

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Single site data may be published/presented prior to the publication of multi-center data from overall study if agreed to by the sponsor in writing, or 12 months have elapsed following termination or completion of the study, whichever comes first.
Publication restrictions are in place

Restriction type: OTHER