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All Solid TumorsPhase 1/2IP N02NCT01711398

Dose-finding Adaptive Phase I/IIa Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IPP-204106N on Advanced Solid Tumors

A Phase 1/2 study testing Drug in people with All Solid Tumors, run by Elro Pharma at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The experimental plan will consist in: The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the optimal and recommended dose of IPP-204106N using a Bayesian "with memory" design with combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of three… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
All Solid Tumors
What is being tested?
Drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesin 2 countries
Study dates
Jul 2012to Feb 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent obtained prior to initiation of any study-specific procedures for study participation and signed informed consent for tumor biopsy. Informed consent for tumor biopsy is mandatory for patients included in the phase IIa part of the study.
  • Man or woman at least 18 years of age.
  • Histological or cytological confirmed advanced solid tumor, non eligible for curative local treatment or active palliation with systemic therapy.
  • 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.
  • 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.
  • Tumor biopsy available at study entry for patients included in the phase IIa part of the study and if possible for phase I patients.
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  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy more than 3 months according to the investigator's judgment.
  • 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.
  • Adequate hematological counts: neutrophils >=1.5 x 109/L, platelets >=100 x 109/L, hemoglobin >=9 g/dL.
  • Adequate renal function: serum creatinine ≤1.5 × upper limit of normal range (ULN).
  • Adequate hepatic function:
  • Serum bilirubin ≤1.5 × ULN (except for isolated hyperbilirubinemia attributed to Gilbert's syndrome).
  • Alkaline phosphatase, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) ≤2.5 × ULN (or ≤5 × ULN in case of liver metastases).
  • 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.

Who cannot join

  • Hematological malignancy (including lymphomas).
  • 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.
  • Ongoing cardiac arrhythmias of NCI-CTCAE grade ≥2.
  • Active uncontrolled infections.
  • Uncontrolled hypertension.
  • Radiotherapy or chemotherapy within 4 weeks before study entry (6 weeks for nitrosoureas or mitomycin).
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  • Pregnancy or breastfeeding.
  • Participation to another therapeutic clinical trial within the last 4 weeks except studies including treatment with N6L.
  • History of severe allergic reactions.
  • Documented or suspected allergy to any nucleolin antagonist.
  • Documented allergy to excipient (mannitol or chondroitin sulfate) product.
  • Documented allergy to aspirin

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

France2 sites

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Claudius Regaud

    Toulouse, 31300

Other trials in France

Belgium1 site

  • Institut Jules Bordet

    Brussels, 1000

Other trials in Belgium

About this study

Official title: A Non-randomized, Open-label, Multi-centric 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

The experimental plan will consist in:

The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the optimal and recommended dose of IPP-204106N using a Bayesian "with memory" design with combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of three patients. The Bayesian methodology allows updating information as the trial progresses and stopping the trial as soon as the information obtained is deemed to be sufficient. Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I clinical trial with N6L will be used to inform the prior distribution in the present study.

Read more

The decisional part, according to the results of the phase I portion of the study, will define the optimal dose recommended for the phase IIa portion of the study.

The phase IIa portion of the study will confirm the optimal dose, and is designed to evaluate the safety and the preliminary efficacy of IPP-204106N in an expanded patient population treated at the recommended dose of IPP-204106N.

Being tested
Drug
Keywords
solid tumor, peptide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DrugDrug

Study groups in NCT01711398
Study groupRoleWhat they receive
IPP204106NExperimentalNot described
Receives: Drug: Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended optimal dose of intravenous IPP-204106N administered for at least 5 consecutive days.

    Toxicity assessed during cycle 1 (until day 12): number of patients experiencing a dose limiting toxicity (DLT) according to the NCI-CTCAE (v 4.0, May 2009), defined as:

    • Hematological drug-related toxicity: grade 4 neutropenia ≥7 days, grade 4 thrombocytopenia, grade 3 thrombocytopenia with hemorrhage/bleeding, and febrile neutropenia.
    • Nausea, vomiting or diarrhea grade ≥3 despite optimal treatment.
    • Any other drug-related biological or clinical grade ≥3 toxicity.

    Plasma exposure assessed during cycle 1 (on day 1): number of patients reaching targeted plasma drug exposure, i.e. plasma N6L concentration ≥5 µM for at least two hours. This concentration corresponds to active concentration in vitro in human tumor cell lines.

    Measured: up to 18 months

Secondary outcomes (10)

  1. Overall safety of IPP-204106N.

    number of participants with DLT

    Measured: up to 18 months

  2. tumor response rate

    Each patient's best objective response will be determined. The categories for best objective response are CR, PR, SD, PD or NE.

    Measured: up to 24 months

  3. Time to progression (TTP) of IPP-204106N at the recommended dose.

    Analysis of time to progression (TTP) will be performed using in the ITT population using non-parametric method of Kaplan Meier and survival curves (PROC LIFETEST with SAS® software).

    Measured: up to 15 months

  4. genomic and proteomic tumor biomarkers identification

    Genomic and/or proteomic biomarkers analyses may be performed as exploratory analyses, to identify the patients who, based on their individual tumor signature, will be most likely to respond and benefit from IPP-204106N therapy, and will be detailed in a further statistical analysis plan.

    Measured: up to 15 months

  5. tumor response duration of objective responses

    The duration of overall response is measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Measured: up to 15 months

  6. tumor response duration of stabilizations.

    Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest summon study (if the baseline sum is the smallest, this is the reference for calculation of PD).

    Measured: up to 15 months

  7. Progression-free survival (PFS) of IPP-204106N at the recommended dose.

    Analysis of progression-free survival (PFS) will be performed using in the ITT population using non-parametric method of Kaplan Meier and survival curves.

    Measured: up to 15 months

  8. To determine the pharmacokinetic (PK) profile of IPP-204106N during the dose-escalation phase of the study.

    Measured: up to 18 months

  9. to evaluate the tumor growth rate (GR)

    The tumor GR analyses may be performed as exploratory analyses

    Measured: up to 24 months

  10. To evaluate the early metabolic effects of IPP-204106N as measured by 18FDG-PET CT

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01711398
Sponsor's protocol ID
IP N02
Acronym
IP N02
Status last verified
Feb 2015
First submitted
9 Oct 2012
Last updated
12 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Drug in people with All Solid Tumors, run by Elro Pharma at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended optimal dose of intravenous IPP-204106N administered for at least 5 consecutive days. (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01711398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.

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