ACTRN12606000099527
Not yet recruiting
Phase 2
An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced Renal Cell Carcinoma
- Sponsor
- Solbec Pharmaceuticals Ltd
- Enrollment
- 56
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed diagnosis of non\-resectable clear cell or papillary type Renal Cell Carcinoma. 2\. Patients with bi\-dimensionally measurable disease according to RECIST criteria on CT or MRI scanning. 3\. Patients who are able and willing to provide written informed consent to participate in the study. 4\. Patients with adequate haematological, hepatic and renal function. 5\. ECOG performance status of 0\-2\. 6\. Life expectancy of at least 16 weeks. 7\. Must agree to the use of an adequate form of contraception. Negative pregnancy test in female patients of childbearing potential.
Exclusion Criteria
- •1\. Diagnosis with Sarcomatoid, Chromophobe, Collecting duct or Unclassified Renal Cell Carcinoma. 2\. Patients with an active infection requiring oral or intravenous antibiotics. 3\. Patients with significant cardiac or pulmonary disease or other significant medical condition which could impair the ability of the patient to participate. 4\. Patients with recent (\<6 months) peptic ulcerations or upper GI bleeding. 5\. Pregnant or lactating women. 6\. Patients with reactions to the Solanum species. 7\. Active brain or other CNS metastases. 8\. Unwilling or unable to have a venous access device. 9\. Any other active malignancy. 10\. Patients must not have had any radiotherapy for 3 weeks prior to entering the study and must be fully recovered from any acute effects. 11\. Patients must not have had any prior chemotherapy for RCC (prior cytokines, vaccines, antiangiogenic agents or signal transduction agents are permitted). 12\. Patients must not have had any other tumour treatment medications for 30 days prior to entering the study. 13\. Patients must not be actively receiving any other investigational therapy, nor received any experimental agents within the previous 30 days. 14\. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 2
An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with MelanomaAdvanced MelanomaCancer - Malignant melanomaACTRN12606000330549Solbec Pharmaceuticals Ltd56
Completed
Phase 1
A clinical trial to study the safety and efficacy of a new compound P276-00 in the treatment of multiple myelomaHealth Condition 1: null- Multiple MyelomaCTRI/2008/091/000004Piramal Life Science26
Active, not recruiting
Not Applicable
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyAdult HLA-A*02-positive patients who have been diagnosed with unresectable, locally advanced and/or metastatic colorectal cancer before first-line chemotherapy. Patients must have completed a 12 week first-line oxaliplatin-based standard chemotherapy (e.g. FOLFOX or XELOX) with either complete or partial response or stable disease as the outcome.EUCTR2007-005666-12-DEimmatics biotechnologies GmbH90
Active, not recruiting
Not Applicable
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-LVimmatics biotechnologies GmbH9
Active, not recruiting
Not Applicable
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-BGimmatics biotechnologies GmbH90