A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer (CAELYX)
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|ClinicalTrials.gov Identifier: NCT02131506|
Recruitment Status : Terminated (Safety reasons)
First Posted : May 6, 2014
Last Update Posted : February 2, 2016
A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer.
Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq & Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day
1 of each cycle repeated every 21 days.
Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib.
Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible.
All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified .However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.
|Condition or disease||Intervention/treatment||Phase|
|HER-2 Positive Breast Cancer Malignant Neoplasm of Breast||Drug: Lapatinib, Caelyx||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Lapatinib, Caelyx
Drug: Lapatinib, Caelyx
Lapatinib, Caelix: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq & Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die
- MTD (Maximum Tolerated Dose) [ Time Frame: 6 years ]The MTD (Maximum Tolerated Dose) is defined as the dose below that at which two patients have experienced DLT (Dose Limiting Toxicity).
- Anti tumour activity of Lapatinib in combination with Caelyx in terms of Objective Response Rate (CR or PR). [ Time Frame: 6 years ]Response and progression are evaluated using the RECIST Criteria (Response Evaluation Criteria In Solid Tumors).
- Evaluation of toxicity. [ Time Frame: 6 years. ]All patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib, using NCI-CTCAE v.3 (National cancer Institute - Common Terminology Criteria for Adverse Events).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131506
|UO Oncologia medica, IRCCS IRST|
|Meldola, FC, Italy, 47014|
|Principal Investigator:||Dino Amadori, MD||IRST IRCCS, Meldola|