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A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma; Non-Squamous Non-Small-Cell Lung Cancer

Intervention: Carboplatin (Drug); Paclitaxel (Drug); CDP791 10mg/kg (Drug); CDP791 20mg/kg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Tumour response rate at 18 weeks.

Safety and Tolerability

Secondary outcome:

Progression free survival

Time to treatment failure

Overall survival

Safety and Tolerability

Quality of life

Detailed description: This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer. In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791. If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy. Participants will be followed up longterm, so that survival can be measured.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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. Exclusion Criteria:

- Subjects with squamous cell lung carcinoma.

- Subjects with lung lesions located centrally in the chest that involve major blood


- 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


Locations and Contacts

Budapest, Hungary

Deszk, Hungary

Matrahaza, Hungary

Nyiregyhaza, Hungary

Pecs, Hungary

Krakow, Poland

Lodz, Poland

Lublin, Poland

Olsztyn, Poland

Otwock, Poland

Poznan, Poland

Radom, Poland

Szczecin, Poland

Torun, Poland

Warszawa, Poland

Wroclaw, Poland

Zabrze, Poland

Kazan, Russian Federation

Moscow, Russian Federation

Moskow, Russian Federation

Saint Petersburg, Russian Federation

Samara, Russian Federation

Additional Information

Starting date: August 2005
Last updated: September 2, 2011

Page last updated: August 23, 2015

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