NL-OMON53887
Recruiting
Not Applicable
A phase Ib study to investigate the safety and pharmacokinetics of BR-003 in patients undergoing spinal fusion surgery - STX-102
SentryX0 sites6 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SentryX
- Enrollment
- 6
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1\. Males and females aged between 18 years and 80 years (inclusive)
- •2\. Planned for open or percutaneous posterior spinal stabilisation with 4 (for
- •cohort I) or 6 (for
- •cohort II) pedicle screws with a diameter of 5 to 7\.5 mm (inclusive) with or
- •without concomitant
- •posterolateral fusion, vertebral augmentation, intervertebral body fusion
- •devices, osteotomies,
- •and posterior decompression. Only primary instrumented spinal surgery cases can
Exclusion Criteria
- •1\. Concomitant anterior/lateral procedures (e.g. anteriorly placed vertebral
- •cage, anterior plating,
- •2\. Use of ilium screws or use of (additional) pedicle screws, with a size \<
- •5 mm or \> 7\.5 mm.
- •3\. Indication for surgery being:
- •a. Active or previous (para)spinal infection
- •b. Metastatic, malignant or benign tumours of the spine
- •c. Fracture/other traumatic injury
- •4\. Known high risk of intra\-/postoperative surgical complications (e.g.
- •patients having previously
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Assessing the safety and tolerability of oral ruxolitinib in combination with 5-azacitidine in patients with advanced phase myeloproliferative neoplasms (MPN), including myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) arising from MPN.Myeloproliferative neoplasms (MPN), including myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) arising from MPNCancerMalignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissueISRCTN16783472The University of Birmingham (UK)58
Withdrawn
Phase 1
A phase I study of Dz13 drug targeting the c-Jun gene in subjects with melanoma skin cancerin-transit or satellite melanomaCancer - Malignant melanomaACTRN12613000302752The University of New South Wales38
Completed
Phase 1
A Phase Ib Study of Pembrolizumab in Combination with Cisplatin and Pemetrexed in Advanced MPMJPRN-jRCT2080224966MSD K.K.18
Active, not recruiting
Phase 1
study to investigate the safety and clinical activity of APR-246 in combination with dabrafenib in patients with unresectable metastatic melanoma resistant to dabrafenib /trametinib combinatioEUCTR2017-002577-18-BEAPREA THERAPEUTICS AB50
Active, not recruiting
Not Applicable
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myleodysplastic Syndrome.Adult patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).MedDRA version: 17.0Level: LLTClassification code 10024348Term: Leukemia myelogenousSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-001570-14-DEF. Hoffmann-La Roche Ltd.60