An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Renal Cell Carcinoma

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000099527

Acronym

nil

Enrollment

Registered

2006-03-14

Start date

2006-06-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Coramsine Injection. 1.5mg/kg infused over 4 hours, daily for 5 days. Six cycles.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results