A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
1 other identifier
interventional
165
3 countries
21
Brief Summary
A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2005
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2009
CompletedResults Posted
Study results publicly available
April 12, 2022
CompletedApril 12, 2022
April 1, 2022
3.9 years
September 6, 2005
February 8, 2018
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor Response Rate (RR)
Participants are evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al; 2000). The tumor response rate is calculated as the total number of subjects whose best overall response is a complete response (CR)= disappearance of all target lesions; or a partial response (PR) = \>=30 % decrease in the sum of the longest diameter of target lesions, divided by the number of randomized subjects (RS): (CR + PR) / RS.
24 weeks
Secondary Outcomes (5)
Progression Free Survival (PFS)
Up to 57 weeks
Time to Treatment Failure
Up to 57 weeks
Overall Survival
Up to 57 weeks
Duration of Overall Response
Up to 57 weeks
Time to Response
Week 24
Study Arms (3)
Carboplatin/Paclitaxel
EXPERIMENTALCarboplatin and paclitaxel alone.
Carboplatin/Paclitaxel/CDP791 10mg
EXPERIMENTALCarboplatin and paclitaxel plus CDP791 10mg/kg
Carboplatin/Paclitaxel/CDP791 20mg
EXPERIMENTALCarboplatin and paclitaxel plus CDP791 20mg/kg
Interventions
10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles.
6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
Eligibility Criteria
You may qualify if:
- Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma.
- The subject must be aged 18 years or above.
- The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
- Subjects will have measurable disease.
- The subject must be able to understand the information provided to them and to give written informed consent.
- Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator.
- Male subjects must be using a method of contraception judged reliable by the Investigator.
You may not qualify if:
- Subjects with squamous cell lung carcinoma.
- Subjects with lung lesions located centrally in the chest that involve major blood vessels.
- Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
- Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
- Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2.
- Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (21)
Unknown Facility
Budapest, Hungary
Unknown Facility
Deszk, Hungary
Unknown Facility
Mátraháza, Hungary
Unknown Facility
Nyíregyháza, Hungary
Unknown Facility
Pécs, Hungary
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Olsztyn, Poland
Unknown Facility
Otwock, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Radom, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Zabrze, Poland
Unknown Facility
Kazan', Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
UCB (+1 844 599 2273)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 9, 2005
Study Start
August 15, 2005
Primary Completion
June 25, 2009
Study Completion
June 25, 2009
Last Updated
April 12, 2022
Results First Posted
April 12, 2022
Record last verified: 2022-04