A Phase I Dose Escalation Trial of Afanitib Plus Gemcitabine or Afatinib Plus Docetaxel
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01251653
First received: December 1, 2010
Last updated: May 15, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 1, 2010 | ||||
| Last Updated Date | May 15, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary objective is to determine the maximum tolerated dose (MTD) of oral Afatinib given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01251653 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Phase I Dose Escalation Trial of Afanitib Plus Gemcitabine or Afatinib Plus Docetaxel | ||||
| Official Title ICMJE | A Phase I Dose Escalation Trial of Once Daily Oral Treatment BIBW 2992 Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors. | ||||
| Brief Summary | Safety and efficacy of Afatinib given orally with gemcitabine i.v. or with docetaxel i.v. Following the results of this Phase I, the hypothesis that antitumor activity of Afatinib could be augmented by combination with chemotherapy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Pharmacokinetic samples |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | solid tumors |
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| Condition ICMJE | Neoplasms | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | April 2014 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria: 1. histologically or cytologically confirmed diagnosis of any advanced or metastatic relapsed or refractory solid tumor. Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01251653 | ||||
| Other Study ID Numbers ICMJE | 1200.93, 2010-020560-37 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim Pharmaceuticals | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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