Trial Outcomes & Findings for A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT00977561)

Last Updated: 2013-02-25

Results Overview

Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = \[event (progression or death) date or censor date - date of randomization + 1\].

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

Results posted on

2013-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Figitumumab + Cisplatin or Carboplatin + Etoposide Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m\^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter\minute (mg/mL\min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.	Cisplatin or Carboplatin + Etoposide Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
Overall Study STARTED	5	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Figitumumab + Cisplatin or Carboplatin + Etoposide Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m\^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter\minute (mg/mL\min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.	Cisplatin or Carboplatin + Etoposide Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
Overall Study Death	3	2
Overall Study Study terminated	0	2
Overall Study Other	2	0

Baseline Characteristics

A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Figitumumab + Cisplatin or Carboplatin + Etoposide n=5 Participants Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.	Cisplatin or Carboplatin + Etoposide n=4 Participants Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.	Total n=9 Participants Total of all reporting groups
Age Continuous	60.4 years STANDARD_DEVIATION 4.4 • n=5 Participants	53.8 years STANDARD_DEVIATION 11.0 • n=7 Participants	57.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

Population: No analysis of progression-free survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: No analysis of objective response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 3 months until death or 12 months from the date the last participant was randomized

Population: No analysis of overall survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = \[death date (last known alive date) - date of randomization +1\].

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to follow-up (90 days post dose)

Population: All randomized participants who received at least one dose of any agent of the combination were included in the safety analysis.

AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	Figitumumab + Cisplatin or Carboplatin + Etoposide n=5 Participants Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.	Cisplatin or Carboplatin + Etoposide n=4 Participants Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	5 participants	4 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	4 participants	2 participants

SECONDARY outcome

Timeframe: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose

Population: No analysis of Cmax for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose

Population: No analysis of Cmin for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion

Population: No analysis of pharmacokinetics (PK) parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: No analysis of PK parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose

Population: No analysis of ADA response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression

Population: No analysis for cancer dyspnea scale score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression

Population: No analysis for NRS score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline prior to dosing

Population: No analysis of tumor biomarkers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)

Population: No analysis for serum circulating IGF pathway related markers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)

Population: No analysis of total CTCs and IGF-IR-expressing CTCs was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs

Outcome measures

Outcome data not reported

Adverse Events

Figitumumab + Cisplatin or Carboplatin + Etoposide

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Cisplatin or Carboplatin + Etoposide

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Figitumumab + Cisplatin or Carboplatin + Etoposide n=5 participants at risk Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.	Cisplatin or Carboplatin + Etoposide n=4 participants at risk Cisplatin 75 mg/m\^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL\*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m\^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.0% 1/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.0% 1/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Psychotic disorder	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	20.0% 1/5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER