Clinical Trials in France / NCT01481532
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Phase 1
Open Label Clinical Trial of Intravenous Crotoxin Part 3
NCT01481532 · tracked via the Priya Life Science France tracker
Condition(s) studied
Cancer
Investigational drug(s) / intervention(s)
Crotoxin
Crotoxin: Intra patient dose escalation
Study summary
The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.
Eligibility
Subjects will:
1. Be adult patients with histologically confirmed advanced solid tumors (excluding basal cell, colon, pancreatic and stomach cancers) who have progressed despite standard therapy, or for whom no standard therapy exists.
2. Have an ambulatory PS (ECOG 0-1).
3. Have tumor evaluation made within 28 days before study drug administration
4. Have completed radiotherapy or chemotherapy or any other anticancer therapy (including experimental therapy) more than 4 weeks prior to enrolment into the trial and must have recovered from all acute side effects of these treatments
5. Have a life expectancy greater than 3 months
6. Have an age ≥ 18 years
7. Have normal marrow function with the following haematological parameters normal; Hb ≥10g/dl, WBC ≥4.0 x10E9/L, neutrophil count ≥ 2.0 x 10E9/L and platelets ≥100 x10E9 /L
8. Have no medically significant impairment of cardiac or respiratory functions\<
9. Have adequate hepatic function with Total bilirubin 1.5 x N and Transaminases \< 2.5 x N (\< 5 x N in case of liver metastasis).
10. Have no history of prior severe allergic reactions to venoms
11. Have Creatinine clearance \> 50 mL/min.
12. Be on stable doses of any drugs which may affect hepatic drug metabolism or renal drug excretion (e.g.--non-steroidal anti-inflammatory drugs, barbiturates, narcotic analgesics, probenecid). Such drugs should not be initiated while the patient is participating in this study.
13. Not be pregnant or planning to become pregnant
14. Not known to have brain metastases or leptomeningeal involvement. CT-scan or MRI is not required to rule this out unless there is clinical suspicion of central nervous system involvement
15. Not have pleural effusion/ ascites, cystic lesions or bone metastases, as the only assessable lesions
16. Not have a history of other malignancies, except for patients with a cancer free interval of \> 5 years after treatment completion, patients with prior history of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
17. Not have had recent major surgery (within 21 days).
18. Not have a recent history of weight loss \> 10% of current body weight.
19. Not have serious intermittent medical illnesses which would interfere with the ability of the patient to carry out the treatment program.
20. Not be on chronic steroid medication (\> 20mg/day)
21. Not have primary or paraneoplastic myasthenia gravis
22. Be free of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
23. Will agree to participate in the study prior to starting with any specific study procedure, after having signed written informed consent.
24. Be patients of childbearing age willing to use contraceptive for the duration of the study
25. Not live alone and live no further than approximately 30 km away from the hospital, and for the study duration have continuous access to the use of mobile telephone in case of medical emergency
Primary outcome measure(s)
- Tolerability of intra-patient dose escalation — 28 days
Assess the safety and tolerability of Crotoxin administered intravenously to Stage IV cancer patients using intra-patient dose escalation procedure. - Confirmation of the induction of drug tolerance — 28 days
Confirm in a controlled phase I trial that human subjects can be made tolerant to intravenously administered Crotoxin thereby reducing the potential for adverse drug effects
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Saint-Herblain | France |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01481532 on ClinicalTrials.gov ↗ ← All trials in France