Dose-finding adaptive phase I/IIa study to assess safety, tolerability, pharmacokinetics and preliminary efficacy of repeated intravenous IPP-204106N administrations in adult patients with advanced solid tumors

• Conditions: Solid tumors; MedDRA version: 16.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000939-42-BE
• Lead Sponsor: Elro Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-13
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Signed informed consent obtained prior to initiation of any study-specific procedures for study participation and signed informed consent for tumor biopsy and 18FDG PET-CT complementary study. Informed consent for tumor biopsy is mandatory for patients included in the phase IIa part of the study. Informed consent for 18FDG PET-CT study concerns phase I and IIa patients but is not mandatory.
2. Man or woman at least 18 years of age.
3. Histological or cytological confirmed advanced solid tumor, non eligible for curative local treatment or active palliation with systemic therapy.
4. Patients with measurable or evaluable disease (by tumor measurements or by tumor biomarker) with a proof of disease progression. At least one measurable lesion is mandatory for the phase IIa portion of the study.
5. Patients currently under treatment with N6L or patients who have taken part in the Phase I part of the study are eligible for the phase IIa part, according to the investigator’s judgment, irrespective of their tumor status.
6.Tumor biopsy available at study entry for patients included in the phase IIa part of the study and if possible for phase I patients.
7. Eastern Cooperative Oncology Group (ECOG) performance status =2.
8. Life expectancy more than 3 months according to the investigator’s judgment.
9. Recovery from any acute toxicity related to prior therapy. Toxicity should be =grade 1 according to NCI-CTCAE criteria or returned to baseline excluding alopecia.
10.Adequate hematological counts: neutrophils =1.5 x 10^9/L, platelets = 100 x 10^9/L, hemoglobin = 9 g/dL.
11. Adequate renal function: serum creatinine =1.5 × upper limit of normal range (ULN).
12. Adequate hepatic function:
• Serum bilirubin =1.5 × ULN (except for isolated hyperbilirubinemia attributed to Gilbert’s syndrome).
• Alkaline phosphatase (or = 5 x ULN in case of liver or bone metastases), aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) =2.5 × ULN (or =5 × ULN in case of liver metastases).
13. All women of child-bearing potential must use adequate contraception throughout the duration of the study, or their partner must be surgically sterilized. The pre-study pregnancy test must be negative for women with reproductive potential. Women who have been surgically sterilized or are at least two years post-menopausal may be enrolled and do not need birth control.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Hematological malignancy (including lymphomas).
2. Any of the following within the 6 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, stroke, including transient ischemic attack, or pulmonary embolism.
3. Ongoing cardiac arrhythmias of NCI-CTCAE grade =2.
4. Active uncontrolled infections.
5. Uncontrolled hypertension.
6. Radiotherapy or chemotherapy within 4 weeks before study treatment (6 weeks for nitrosoureas or mitomycin).
7. Pregnancy or breastfeeding.
8. Participation to another therapeutic clinical trial within the last 4 weeks except studies including treatment with N6L.
9. History of severe allergic reactions.
10. Documented or suspected allergy to any nucleolin antagonist.
11. Documented allergy to excipient (mannitol or chondroitin sulfate) product
12. Documented allergy to Aspirin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified