Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03430518|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|HER2-Negative Metastatic Breast Cancer Recurrent Ovarian Cancer||Drug: Durvalumab Drug: Eribulin||Phase 1|
Study Duration: Accrual will take place over the course of 16 months. Patients will be treated until unacceptable toxicity or disease progression (expected on average for 6 months) and then followed for one year thereafter.
Objectives: Phase I: To determine the the recommended phase II dose of eribulin in combination with Durvalumab
This study will evaluate the recommended Phase 2 combination dose (RP2D) of eribulin with durvalumab. If two or more out of 6 patients experience a dose limiting toxicity (DLT) at dose level I or II, the dose level below that level will be considered the RP2D. If all 3 patients enter dose level-I and experience DLT, the study will be terminated. If the highest level has been reached and < 33% of patients have experienced DLT, that will be considered the RP2D.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study Evaluating the Safety and Tolerability of Durvalumab (MEDI4736) (Anti-PDL1) in Combination With Eribulin in Patients With HER2-Negative Metastatic Breast Cancer and Recurrent Ovarian Cancer|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||June 14, 2019|
|Estimated Study Completion Date :||February 12, 2021|
Experimental: Her2-negative Metastatic Breast Ca and Recurrent Ovarian Ca
Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian cancer
1.12g given IV on day 1 every 21 day cycle
1.1 mg/m2 IV on day 8 of every 21 day cycle in the first 3 patients, then increased to 1.4mg/m2 IV on day 1 and day 8 of every 21 day cycle. If significant toxicity occurs in patients given the 1.1mg/m2 IV dose, then subsequent patients with receive eribulin 0.7mg/m2 IV on day 1 and day 8 of every 21 day cycle.
- The dose-limiting toxicity (DLT) rate [ Time Frame: 42 days ]A DLT is defined as a ≥ Grade 3 or 4 study drug-related adverse event (using NCI CTCAE Version 4.03) that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
- Number of Adverse events [ Time Frame: 6 months ]Adverse events associated with eribulin when administered in combination with durvalumab will be described according to the Medical Dictionary for Regulatory Activities (MedDRA) by system organ classes.
- Objective response rate (ORR) [ Time Frame: 6 months ]Objective response rate (ORR) is measured as the proportion of patients who have achieved complete response, partial response (CR, PR) according to Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria. irCR, complete disappearance of all measurable and non-measurable lesions. Lymph nodes must decrease to < 10 mm in short axis. Confirmation of response is not mandatory. irPR, decrease of ≥ 30% in TMTB relative to baseline, non-target lesions are irNN, and no unequivocal progression of new non-measurable lesions.
- Progression free survival (PFS) [ Time Frame: 16 months ]Progression free survival (PFS) is measured from the start of first treatment until the criteria for progression are met or death, whichever occurs earlier. Patients without documented progression/death will be censored at the last disease assessment date.
- Overall survival (OS) [ Time Frame: 6 months ]Overall survival (OS) is measured from the start of first treatment until death due to any cause. Patients without documented death at the time of analysis will be censored at the date last known to be alive.
- ECOG performance status [ Time Frame: 6 months ]Eastern Cooperative Oncology Group (ECOG) performance status. Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Grade 5: Dead
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): NCT03430518
|Contact: Neha Kumarley, MSfirstname.lastname@example.org|
|Contact: Jalwa Afroz, BSemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Neha Kumarley, MS 212-824-7659 firstname.lastname@example.org|
|Contact: Jalwa Afroz, BS 212-824-7320 email@example.com|
|Principal Investigator: Amy Tiersten, MD|
|Principal Investigator:||Amy Tiersten, MD||Icahn School of Medicine at Mount Sinai|