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Open Label Clinical Trial of Intravenous Crotoxin

This study is currently recruiting participants.
Verified July 2017 by Celtic Biotech Ltd
ClinicalTrials.gov Identifier:
First Posted: November 29, 2011
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celtic Biotech Ltd
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.

Condition Intervention Phase
Cancer Drug: Crotoxin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase I Clinical Trial of Crotoxin in Patients With Advanced Cancer Using an Intravenous Route of Administration

Further study details as provided by Celtic Biotech Ltd:

Primary Outcome Measures:
  • Tolerability of intra-patient dose escalation [ Time Frame: 54 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 [ Time Frame: 54 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

Secondary Outcome Measures:
  • Assessment of drug efficacy [ Time Frame: 54 days ]
    Document any objective anti-tumour responses that occur in patients treated on this protocol.

Estimated Enrollment: 18
Actual Study Start Date: February 28, 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 2
The second cohort will include up to 18 patients with doses of 0.08 to 0.64 mg/m2 in which the dose escalation speed will be faster. Drug is administered over 48 hour intervals using infusion pumps; treating on an outpatient basis. Subjects will receive increasing doses over the course of 35 treatment days (15 dose levels).
Drug: Crotoxin
Intra patient dose escalation
Other Name: antihistamine

Detailed Description:

Crotoxin has been shown to induce neurotoxic tolerance in animals allowing them to receive high doses associated with effective anti-tumor activity in the absence of adverse side effects.

The study plans to demonstrate this effect in human subjects using two dose escalation protocols; slow and fast. It is believed that this approach will prevent toxic side effects to subjects.

The route of administration has not been employed clinically and is designed to avoid the myonecrotic effects of intramuscular injections. The target maximum dose is almost double that off the previously reported MTD.

The protocol also incorporates an active suppression of the allergic reaction by pre-treatment administration of antihistamines.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be adult patients with histologically confirmed advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists.
  2. Have an ambulatory PS (ECOG 0-1).
  3. Have tumour evaluation made within 28 days before study drug administration (patients with non measurable lesions according to the RECIST guidelines not previously irradiated are allowed to enter the trial).
  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 between 18 and 75 years
  7. Have normal marrow function with the following haematological parameters normal; Hb ≥10g/dl, WBC ≥4.0 x109/L, neutrophil count ≥ 2.0 x 109/L and platelets ≥100 x109 /L
  8. Have no medically significant impairment of cardiac or respiratory functions
  9. Have adequate hepatic function with Total bilirubin lower or equal to 1.5 x N and Transaminases lower or equal to 2.5 x N (lower or equal to 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. Will agree to participate in the study prior to starting with any specific study procedure, after having signed written informed consent.

Exclusion Criteria:

  1. Pregnant or planning to become pregnant
  2. 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
  3. Have pleural effusion/ ascites, cystic lesions or bone metastases, as the only assessable lesions
  4. Receiving any other experimental or anti-cancer therapy within 30 days before first study drug administration (except antalgic radiotherapy and hormonotherapy)
  5. 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
  6. Have had recent major surgery (within 21 days).
  7. Have a recent history of weight loss > 10% of current body weight.
  8. Have serious intermittent medical illnesses which would interfere with the ability of the patient to carry out the treatment program.
  9. On chronic steroid medication (> 20mg/day)
  10. Have primary or paraneoplastic myasthenia gravis
  11. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481532

Contact: Dorothy Bray, Ph.D. +33146334535 dorothy.bray@immunoclin.com

Salpetriere Hospital Recruiting
Paris, France, 75013
Contact: Maria A Gil-Delgado, MD    +33 1 42 16 05 08    marian-gil-delgado@psl.aphp.fr   
Principal Investigator: Maria A Gil-Delgado, MD         
Sponsors and Collaborators
Celtic Biotech Ltd
Principal Investigator: Maria A Gil-Delgado, MD Salpetriere Hospital, Paris, France
  More Information

Responsible Party: Celtic Biotech Ltd
ClinicalTrials.gov Identifier: NCT01481532     History of Changes
Other Study ID Numbers: CRTX01
First Submitted: October 11, 2011
First Posted: November 29, 2011
Last Update Posted: July 21, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Celtic Biotech Ltd:
Antineoplastic agent