Status:
COMPLETED
S 81694 Plus Paclitaxel in Metastatic Breast Cancer
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Metastatic Breast Cancer
Metastatic Triple Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastati...
Eligibility Criteria
Inclusion
- For Phase I :
- Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therapy or for which the standard therapy is considered unsuitable;
- Patient must have at least one evaluable or measurable metastatic lesion (lesions as defined by revised Response Evaluation Criteria in Solid Tumors).
- For Phase II :
- Histologically or cytologically confirmed advanced inoperable triple negative breast cancer with no prior anticancer therapy regimen in metastatic setting;
- Patient with a minimum washout period of 12 months following previous taxane based adjuvant therapy;
- Patient must have at least one measurable metastatic lesion. Ascites, pleural effusion, and bone metastases are not considered measurable;
- Acceptance of pre-treatment metastatic biopsies for all patients and on-treatment metastatic biopsies in selected centres.
- For the whole study:
- Male or female subjects aged ≥ 18 years old, or legal age of the majority in the country;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy of at least 3 months;
- Adequate haematological function based on the last assessment performed within 7 days prior to the first IMP (investigational medicinal product) administration;
- Adequate renal function based on the last assessment performed within 7 days prior to the first IMP administration;
- Adequate hepatic function based on the last assessment performed within 7 days prior to the first IMP administration;
- Female participant of childbearing potential must have a negative pregnancy test (serum) within 7 days prior to the first day of test drug administration. Effective contraception both for female patients of childbearing potential and male patients with parteners of childbearing potential.
Exclusion
- Other active malignancy within the last 3 years (except for basal cell carcinoma or a non-invasive/in situ cervical cancer or intra-mucosal gastro-intestinal cancers that were treated curatively);
- Presence of grade ≥ 2 toxic effects (excluding alopecia) due to prior cancer therapy;
- Known hypersensitivity to the IMP (S 81694 and paclitaxel) or their excipients;
- Evidence of peripheral neuropathy of grade 2 or higher;
- Participant previously received paclitaxel and discontinued due to toxicity related to paclitaxel;
- Participant known as refractory to taxanes;
- Any prior cancer therapy within 4 weeks or 5 half-life (whichever is the shorter) before the first IMP administration;
- Participant with current, serious, uncontrolled infections;
- Participant with brain metastasis or leptomeningeal metastasis (except patients with brain metastasis that have been stable post-radiation therapy and who are off steroids for \> 2 months);
- History of cardiac disease;
- Uncontrolled arterial hypertension;
- Presence of risk factors for torsades de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome);
- Any clinically significant medical condition (e.g. organ dysfunction) or laboratory abnormality likely to jeopardize the patient's safety or to interfere with the conduct of the study, in the investigator's opinion.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03411161
Start Date
January 4 2018
End Date
June 8 2020
Last Update
May 25 2021
Active Locations (6)
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1
Institut Jules Bordet Clinique Oncologie Médicale
Brussels, Belgium, 1000
2
UZ Leuven Campus Gasthuisberg Dept. of General Medical
Leuven, Belgium, 3000
3
Institut de Cancérologie de l'Ouest site Saint Herblain
Saint-Herblain, France, 44805
4
Chiba cancer center Breast surgery
Chiba, Japan, 2608717