NCT02528526

Brief Summary

The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe and tolerated in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At level of MTD, additional patients will be included aimed for assessing the efficacy profile in these neoplasia entities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

November 11, 2014

Last Update Submit

August 18, 2015

Conditions

Pancreatic NeoplasmsHepatocellular CancerCholangiocarcinomaColorectal Neoplasms

Keywords

HypoxiaPancreatic NeoplasmsHepatocellular CancerCholangiocarcinomaColorectal NeoplasmsTreatment

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability as measured by collection of adverse effects information

    Safety variables and patient tolerance as measured by collection of adverse effects information according to Common Terminology Criteria for Adverse Events (CTCAE)

    10 weeks

Secondary Outcomes (2)

  • Efficacy as measured by FDG-PET scan

    5 months

  • Efficacy as measured by MRI

    5 months

Study Arms (1)

Treatment

EXPERIMENTAL

Add-on application of Myo-inositol trispyrophosphate, total of 9 times, 3 applications per week, over 3 weeks.

Drug: OXY111A

Interventions

OXY111ADRUG

OXY111A intravenous infusion

Also known as: Myo-inositol trispyrophosphate
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study Indication: patients diagnosed for non-resectable hepato-pancreato-biliary or gastrointestinal neoplasm
  • Male and Female patients ≥ 18 years of age
  • Signed Informed Consent after being informed
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≥ 2 at study entry.
  • A life-expectancy of \>3 months
  • Adequate hematologic and renal function
  • Use of effective contraception (per the institutional standard), if procreative potential exists
  • Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy (palliative radiation therapy is allowed)
  • Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center

You may not qualify if:

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
  • Women who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Visceral Surgery

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (7)

  • Aprahamian M, Bour G, Akladios CY, Fylaktakidou K, Greferath R, Soler L, Marescaux J, Egly JM, Lehn JM, Nicolau C. Myo-InositolTrisPyroPhosphate treatment leads to HIF-1alpha suppression and eradication of early hepatoma tumors in rats. Chembiochem. 2011 Mar 21;12(5):777-83. doi: 10.1002/cbic.201000619. Epub 2011 Mar 2.

    PMID: 21370375BACKGROUND

  • Derbal-Wolfrom L, Pencreach E, Saandi T, Aprahamian M, Martin E, Greferath R, Tufa E, Choquet P, Lehn JM, Nicolau C, Duluc I, Freund JN. Increasing the oxygen load by treatment with myo-inositol trispyrophosphate reduces growth of colon cancer and modulates the intestine homeobox gene Cdx2. Oncogene. 2013 Sep 5;32(36):4313-8. doi: 10.1038/onc.2012.445. Epub 2012 Oct 8.

    PMID: 23045284BACKGROUND

  • Kieda C, El Hafny-Rahbi B, Collet G, Lamerant-Fayel N, Grillon C, Guichard A, Dulak J, Jozkowicz A, Kotlinowski J, Fylaktakidou KC, Vidal A, Auzeloux P, Miot-Noirault E, Beloeil JC, Lehn JM, Nicolau C. Stable tumor vessel normalization with pO(2) increase and endothelial PTEN activation by inositol trispyrophosphate brings novel tumor treatment. J Mol Med (Berl). 2013 Jul;91(7):883-99. doi: 10.1007/s00109-013-0992-6. Epub 2013 Mar 9.

    PMID: 23471434BACKGROUND

  • Raykov Z, Grekova SP, Bour G, Lehn JM, Giese NA, Nicolau C, Aprahamian M. Myo-inositol trispyrophosphate-mediated hypoxia reversion controls pancreatic cancer in rodents and enhances gemcitabine efficacy. Int J Cancer. 2014 Jun 1;134(11):2572-82. doi: 10.1002/ijc.28597. Epub 2013 Nov 25.

    PMID: 24214898BACKGROUND

  • Fylaktakidou KC, Lehn JM, Greferath R, Nicolau C. Inositol tripyrophosphate: a new membrane permeant allosteric effector of haemoglobin. Bioorg Med Chem Lett. 2005 Mar 15;15(6):1605-8. doi: 10.1016/j.bmcl.2005.01.064.

    PMID: 15745806BACKGROUND

  • Schneider MA, Linecker M, Fritsch R, Muehlematter UJ, Stocker D, Pestalozzi B, Samaras P, Jetter A, Kron P, Petrowsky H, Nicolau C, Lehn JM, Humar B, Graf R, Clavien PA, Limani P. Phase Ib dose-escalation study of the hypoxia-modifier Myo-inositol trispyrophosphate in patients with hepatopancreatobiliary tumors. Nat Commun. 2021 Jun 21;12(1):3807. doi: 10.1038/s41467-021-24069-w.

    PMID: 34155211DERIVED

  • Limani P, Linecker M, Kron P, Samaras P, Pestalozzi B, Stupp R, Jetter A, Dutkowski P, Mullhaupt B, Schlegel A, Nicolau C, Lehn JM, Petrowsky H, Humar B, Graf R, Clavien PA. Development of OXY111A, a novel hypoxia-modifier as a potential antitumor agent in patients with hepato-pancreato-biliary neoplasms - Protocol of a first Ib/IIa clinical trial. BMC Cancer. 2016 Oct 19;16(1):812. doi: 10.1186/s12885-016-2855-3.

    PMID: 27756258DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsLiver NeoplasmsCholangiocarcinomaColorectal NeoplasmsHypoxia

Interventions

inositol trispyrophosphate

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre Alain, Clavien

    University Hospital Zurich, Visceral Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Alain Clavien, MD, PhD

CONTACT

+41 (0)44 255 33 00clavien@access.uzh.ch

Perparim Limani, MD

CONTACT

+41 (0)44 255 33 00perparim.limani@usz.ch

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

August 19, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

CH(1)