NL-OMON46450
Completed
Not Applicable
Phase I/II trial of S 81694 administered intravenously in;combination with paclitaxel to evaluate the safety,;pharmacokinetic and efficacy in metastatic breast cancer - Phase I/II trial of S81694 plus paclitaxel in metastatic Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- metastatic breast cancer
- Sponsor
- Servier R&D Benelux
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Phase I :;\- Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therap
Exclusion Criteria
- •\- 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 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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Phase I/II trial of S 81694 plus paclitaxel in metastatic BreastCancerEUCTR2017-002459-27-NLInstitut de Recherches Internationales Servier117
Active, not recruiting
Phase 1
Phase I/II trial of S 81694 plus paclitaxel in metastatic BreastCancerEUCTR2017-002459-27-BEInstitut de Recherches Internationales Servier120
Active, not recruiting
Phase 1
Phase I/II trial of S 81694 plus paclitaxel in metastatic BreastCancerMetastatic Breast Cancer (mBC) and metastatic Triple Negative Breast Cancer (mTNBC)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-002459-27-FRInstitut de Recherches Internationales Servier120
Completed
Phase 1
S 81694 Plus Paclitaxel in Metastatic Breast CancerMetastatic Breast CancerMetastatic Triple Negative Breast CancerNCT03411161Institut de Recherches Internationales Servier22
Completed
Phase 2
A Phase Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancerbreast cancermammcarcinoma10006291NL-OMON43947Boehringer Ingelheim12