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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00959946




Registration number
NCT00959946
Ethics application status
Date submitted
14/08/2009
Date registered
17/08/2009
Date last updated
22/02/2013

Titles & IDs
Public title
Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer
Scientific title
A Phase 1/2, Open-Label Study Of Bosutinib Administered In Combination With Capecitabine In Subjects With Solid Tumor And ErbB2 Negative Locally Advanced Or Metastatic Breast Cancer
Secondary ID [1] 0 0
B1871011
Secondary ID [2] 0 0
3160A6-2208
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer (Parts 1 and 2) 0 0
Advanced Pancreatic Cancer (Part 1) 0 0
Advanced Colorectal Cancer (Part 1) 0 0
Advanced Cholangiocarcinoma (Part 1) 0 0
Advanced Glioblastoma Multiforme (Part 1) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bosutinib
Treatment: Drugs - Capecitabine

Experimental: 1 - In part 1 (phase 1), ascending and descending multiple oral doses of bosutinib + capecitabine. Doses in part 1 include capecitabine 750 mg/m2 BID on days 1-14 + bosutinib 200 mg QD; capecitabine 625 mg/m2 BID on days 1-14 + bosutinib 300 mg QD. Depending on safety, capecitabine can also be administered at 1000 mg/m2 BID and bosutinib can be administered at 200 mg/m2 QD. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).


Treatment: Drugs: Bosutinib
Doses in part 1 include bosutinib 200 mg QD; bosutinib 300 mg QD. Depending on safety bosutinib can be administered at 200 mg/m2 QD. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).

Treatment: Drugs: Capecitabine
Doses in part 1 include capecitabine 750 mg/m2 BID on days 1-14; capecitabine 625 mg/m2 BID on days 1-14. Depending on safety, capecitabine can also be administered at 1000 mg/m2 BID. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) - Part 1
Timepoint [1] 0 0
Part 1 Baseline up to Day 21
Primary outcome [2] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1
Timepoint [2] 0 0
Part 1 Baseline up to 28 days after last dose of study treatment
Primary outcome [3] 0 0
Percentage of Participants With Objective Response - Part 2
Timepoint [3] 0 0
Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Secondary outcome [1] 0 0
Best Overall Response - Part 1
Timepoint [1] 0 0
Part 1 Baseline, every 6 weeks up to 6 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - Part 2
Timepoint [2] 0 0
Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Secondary outcome [3] 0 0
Clinical Benefit Rate - Part 2
Timepoint [3] 0 0
Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Secondary outcome [4] 0 0
Duration of Response (DR) - Part 2
Timepoint [4] 0 0
Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose
Secondary outcome [5] 0 0
Maximum Observed Plasma Concentration (Cmax) - Part 2
Timepoint [5] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Secondary outcome [6] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 2
Timepoint [6] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Secondary outcome [7] 0 0
Apparent Volume of Distribution (Vz/F) - Part 2
Timepoint [7] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Secondary outcome [8] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - Part 2
Timepoint [8] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Secondary outcome [9] 0 0
Apparent Oral Clearance (CL/F) - Part 2
Timepoint [9] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Secondary outcome [10] 0 0
Terminal-Phase Disposition Rate Constant (?z) - Part 2
Timepoint [10] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1
Secondary outcome [11] 0 0
Plasma Decay Half-Life (t1/2) - Part 2
Timepoint [11] 0 0
0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1

Eligibility
Key inclusion criteria
Part 1:

* Ages eligible for study: 18 years or older.
* Male and female.
* Confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.

Part 2:

* Ages eligible for study: 18 years or older.
* Female.
* Confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or loco-regional recurrent breast cancer that is not amenable to curative treatment with surgery or radiotherapy.
* Documented ER+ and/or PgR+/erbB2- or ER-/PgR-/erbB2- tumor based upon recently analyzed biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1:

* Prior bosutinib, or any other prior Src inhibitor.
* Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity.

Part 2:

* Prior bosutinib, or any other prior Src inhibitor prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
* Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months.
* erbB2+ breast cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5037 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
France
State/province [4] 0 0
Saint Herblain
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Spain
State/province [6] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00959946