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Clinical Trials/RPCEC00000196
RPCEC00000196
Not yet recruiting
Phase 1

Evaluation of the safety and pharmacokinetics and determining the maximum tolerable dose with the use of antitumor peptide CIGB-552 in solid tumors. Phase I.

Center for Genetic Engineering and Biotechnology (CIGB)0 sitesMay 22, 2015
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ConditionsSolid tumors

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Solid tumors
Sponsor
Center for Genetic Engineering and Biotechnology (CIGB)
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 22, 2015
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Center for Genetic Engineering and Biotechnology (CIGB)

Eligibility Criteria

Inclusion Criteria

  • •1\) Age \=18 years.
  • •2\) Patients who meet the diagnostic criteria.
  • •3\) Values normal blood glucose values according institucionales.l
  • •4\) General status ECOG 0\-2\.
  • •5\) Patients who have normal functioning of organs and bone marrow defined by the following parameters:
  • •\- Haemoglobin \= 9 g / L.
  • •\- Leukocytes \= 3 x 109 / L.
  • •\- Absolute neutrophil count \= 1\.5 x 109 / L.
  • •\- Platelet count \= 150\-250 x 109 / L.
  • •\- Total bilirubin: Within normal limits as institutional values.

Exclusion Criteria

  • •1\) Patients who are of childbearing potential not using adequate contraceptive method (IUDs, barrier methods, hormones or tubal ligation) for men (vasectomy, condom use) prior to their inclusion in the study and / or while participating in the clinical trial.
  • •2\) Patients with a positive pregnancy test, breastfeeding and postpartum women.
  • •3\) Patients suffering from severe allergic diseases.
  • •4\) diabetic patients.
  • •5\) That have been treated with other biological therapy six months preceding the date of inclusion.

Outcomes

Primary Outcomes

Not specified

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