A Phase 1 interventional study of CP-751,871 and Cisplatin in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-21.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 46 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: CP-751,871 · Drug: Cisplatin · Drug: Gemcitabine · Drug: Pemetrexed
CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).
Cisplatin 75\* mg/m2 or 80\* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles. \* 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine
Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles
Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle
Number of Participants With Dose-limiting Toxicities (DLT)
Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count \<500 cells/cubic millimeter \[mm\^3\]) \>=7 days, febrile neutropenia (Gr 3, fever \>=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet \<25,000 cells/mm\^3), Gr 3 thrombocytopenia \>=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment
Time frame: Start of treatment up to end of Cycle 1, Day 21
Concentration at the End of Infusion (Cinf) for Figitumumab
Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods
Time frame: Cycle 1 for dose escalation and Cycle 4 for dose expansion
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods
Time frame: 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion
Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab
Concentration at the end of Cycle 4
Time frame: 0 (pre-dose) in Cycle 5 Day 1
Maximum Observed Plasma Concentration (Cmax) for Cisplatin
Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab
Time frame: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
Time frame: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2
Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab
Time frame: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
Time frame: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8
Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
Time frame: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
Time frame: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2
Percentage of Participants With Objective Response or Prolonged Stabilization
Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging \>= 4 weeks after initial response
Time frame: Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)
Progression-Free Survival (PFS)
Time from the date of enrollment to date of documented disease progression, or death due to any cause
Time frame: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)
Duration of Response (DR)
For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression
Time frame: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
Time frame: 30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)
Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels
To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment
Time frame: Baseline, Day 8, end of study
Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1
Time frame: Cycle 1, up to Day 21
Recommended Phase 2 Dose (RP2D)
The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration
Time frame: Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19
| Milestone | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation | Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion | Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion | Figitumumab 20 mg/kg Pemetrexed Expansion |
|---|---|---|---|---|---|---|
| Started | 6 | 3 | 6 | 10 | 8 | 13 |
| Treated | 6 | 3 | 6 | 10 | 7 | 13 |
| Completed | 0 | 0 | 0 | 0 | 1 | 0 |
| Not completed | 6 | 3 | 6 | 10 | 7 | 13 |
| Withdrew: Death | 4 | 1 | 4 | 5 | 1 | 10 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Other | 2 | 2 | 2 | 3 | 3 | 3 |
| Withdrew: Enrolled, not treated | 0 | 0 | 0 | 0 | 1 | 0 |
Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count \<500 cells/cubic millimeter \[mm\^3\]) \>=7 days, febrile neutropenia (Gr 3, fever \>=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet \<25,000 cells/mm\^3), Gr 3 thrombocytopenia \>=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment
| participants | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation |
|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) | 0 | 0 | 1 |
Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods
| mg/liter (L) | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation | Figitumumab 20 mg/kg Expansion |
|---|---|---|---|---|
| Concentration at the End of Infusion (Cinf) for Figitumumab | 120.4 ± 26.690 | 137.0 ± NA | 435.0 ± 129.01 | 513.4 ± 136.58 |
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods
| mg*hr/L | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation | Figitumumab 20 mg/kg Expansion |
|---|---|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab | 26020 ± 6780.6 | 21500 ± NA | 84100 ± 18983 | 121200 ± 50493 |
Concentration at the end of Cycle 4
| mg/L | Figitumumab 20 mg/kg Expansion |
|---|---|
| Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab | 113.6 ± 47.266 |
Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab
| nanogram (ng)/mL | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1) | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2) | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1) | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2) |
|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for Cisplatin | 3.816 ± 1.5485 | 3.880 ± 0.8490 | 2.845 ± 0.8804 | 3.490 ± 1.1435 |
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
| ng*hr/L | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1) | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2) | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1) | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2) |
|---|---|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin | 38.23 ± 7.2762 | 45.18 ± 15.005 | 37.12 ± 8.7975 | 48.29 ± 13.931 |
Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab
| ng/L | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1) | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2) |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for Gemcitabine | 12.85 ± 6.9644 | 23.97 ± 18.764 |
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
| ng*hr/L | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1) | Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2) |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine | 6.665 ± 3.0299 | 12.53 ± 7.5062 |
Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
| ng/mL | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1) | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2) |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for Pemetrexed | 72.96 ± 25.581 | 93.13 ± 12.560 |
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab
| ng*hr/L | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1) | Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2) |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed | 132.2 ± 71.512 | 161.6 ± 39.335 |
Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging \>= 4 weeks after initial response
| Percentage of participants | Overall Population | Figitumumab 20 mg/kg With Gemcitabine and Cisplatin | Figitumumab 20 mg/kg Expansion With Pemetrexed |
|---|---|---|---|
| Percentage of Participants With Objective Response or Prolonged Stabilization | 53.3 (37.9 to 68.3) | 56.5 (34.5 to 76.8) | 46.2 (19.2 to 74.9) |
Time from the date of enrollment to date of documented disease progression, or death due to any cause
| months | Overall Population | Figitumumab 20 mg/kg With Gemcitabine and Cisplatin | Figitumumab 20 mg/kg Expansion With Pemetrexed |
|---|---|---|---|
| Progression-Free Survival (PFS) | 5.7 (2.0 to 6.5) | 6.5 (1.7 to 10.2) | 5.4 (1.6 to 5.7) |
For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression
No measurements were reported for this outcome.
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
| Percentage of participants | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation | Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion | Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion | Figitumumab 20 mg/kg Pemetrexed Expansion |
|---|---|---|---|---|---|---|
| C1D1 - Negative | 50.0 | 33.3 | 50.0 | 80.0 | 100 | 100 |
| C1D1 - Positive | 0 | 0 | 0 | 0 | 0 | 0 |
| C1D1 - Not determined | 50.0 | 66.7 | 50.0 | 20.0 | 0 | 0 |
| C4D1 - Negative | 16.7 | 0 | 50.0 | 30.0 | 71.4 | 53.8 |
| C4D1 - Positive | 0 | 0 | 0 | 0 | 0 | 0 |
| C4D1 - Not determined | 83.3 | 100 | 50.0 | 70.0 | 28.6 | 46.2 |
| End of Study - Negative | 83.3 | 0 | 50.0 | 20.0 | 42.9 | 46.2 |
| End of Study - Positive | 0 | 0 | 0 | 0 | 0 | 0 |
| End of Study - Not determined | 16.7 | 100 | 50.0 | 80.0 | 51.7 | 53.8 |
| Follow Up - Negative | 0 | 0 | 0 | 0 | 14.3 | 0 |
| Follow Up - Positive | 0 | 0 | 0 | 0 | 0 | 0 |
| Follow Up - Not determined | 100 | 100 | 100 | 100 | 85.7 | 100 |
To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment
| ng/mL | Overall Population |
|---|---|
| Baseline | 124.88 (91 to 143) |
| End of study | 543.63 (343 to 694) |
The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1
| mg/kg | Overall Population |
|---|---|
| Maximum Tolerated Dose (MTD) | 20 |
The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration
| mg/kg | Overall Participapnts |
|---|---|
| Recommended Phase 2 Dose (RP2D) | 20 |
Collected over Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Figitumumab 6 mg/kg | — | 3/6 (50%) | 6/6 (100%) |
| Figitumumab 10 mg/kg | — | 2/3 (66.7%) | 3/3 (100%) |
| Figitumumab 20 mg/kg Dose Escalation | — | 3/6 (50%) | 6/6 (100%) |
| Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion | — | 7/10 (70%) | 10/10 (100%) |
| Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion | — | 2/7 (28.6%) | 7/7 (100%) |
| Figitumumab 20 mg/kg Pemetrexed Expansion | — | 8/13 (61.5%) | 13/13 (100%) |
| Event | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation | Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion | Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion | Figitumumab 20 mg/kg Pemetrexed Expansion |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/6 | 1/3 | 0/6 | 1/10 | 0/7 | 1/13 |
| Therapeutic agent toxicityInjury, poisoning and procedural complications | 0/6 | 1/3 | 0/6 | 0/10 | 0/7 | 0/13 |
| HyperglycaemiaMetabolism and nutrition disorders | 2/6 | 0/3 | 0/6 | 0/10 | 0/7 | 0/13 |
| Renal failureRenal and urinary disorders | 0/6 | 1/3 | 0/6 | 1/10 | 1/7 | 0/13 |
| NeutropeniaBlood and lymphatic system disorders | 1/6 | 0/3 | 0/6 | 0/10 | 0/7 | 0/13 |
| Abdominal painGastrointestinal disorders | 0/6 | 0/3 | 1/6 | 0/10 | 0/7 | 0/13 |
| NauseaGastrointestinal disorders | 0/6 | 0/3 | 1/6 | 0/10 | 0/7 | 0/13 |
| Chest painGeneral disorders | 1/6 | 0/3 | 0/6 | 0/10 | 0/7 | 0/13 |
| Disease progressionGeneral disorders | 0/6 | 0/3 | 1/6 | 0/10 | 1/7 | 2/13 |
| PainGeneral disorders | 0/6 | 0/3 | 1/6 | 0/10 | 0/7 | 0/13 |
| Event | Figitumumab 6 mg/kg | Figitumumab 10 mg/kg | Figitumumab 20 mg/kg Dose Escalation | Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion | Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion | Figitumumab 20 mg/kg Pemetrexed Expansion |
|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 6/6 | 1/3 | 4/6 | 5/10 | 5/7 | 8/13 |
| NeutropeniaBlood and lymphatic system disorders | 5/6 | 2/3 | 5/6 | 3/10 | 5/7 | 8/13 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/6 | 1/3 | 2/6 | 2/10 | 3/7 | 5/13 |
| AstheniaGeneral disorders | 4/6 | 2/3 | 5/6 | 6/10 | 5/7 | 6/13 |
| HyperglycaemiaMetabolism and nutrition disorders | 5/6 | 2/3 | 5/6 | 5/10 | 4/7 | 10/13 |
| AnaemiaBlood and lymphatic system disorders | 4/6 | 0/3 | 3/6 | 2/10 | 5/7 | 5/13 |
| Decreased appetiteMetabolism and nutrition disorders | 3/6 | 0/3 | 2/6 | 0/10 | 5/7 | 6/13 |
| ConstipationGastrointestinal disorders | 4/6 | 0/3 | 3/6 | 2/10 | 4/7 | 3/13 |
| VomitingGastrointestinal disorders | 2/6 | 1/3 | 4/6 | 2/10 | 4/7 | 5/13 |
| Disease progressionGeneral disorders | 2/6 | 2/3 | 2/6 | 1/10 | 0/7 | 4/13 |
| Age Continuous(Years) | All Participants |
|---|---|
| Mean | 59.2 ± 8.0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 36 |
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Carcinoma, Non-Small-Cell Lung→
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