Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43617   clinical trials with a EudraCT protocol, of which   7208   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2014-001175-31
    Sponsor's Protocol Code Number:ALM201/0001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-22
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-001175-31
    A.3Full title of the trial
    A phase I open-label multicentre dose-escalation study of subcutaneous ALM201 in patients with advanced ovarian cancer and other solid tumours.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of escalating doses of ALM201 injected below the skin in patients with late stage ovarian cancer and other solid tumours.
    A.4.1Sponsor's protocol code numberALM201/0001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlmac Discovery
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlmac Discovery
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOckham Europe Ltd
    B.5.2Functional name of contact pointALM201/0001 Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressLogan Building, Roslin Biocentre
    B.5.3.2Town/ cityRoslin, Midlothian
    B.5.3.3Post codeEH25 9TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441312006320
    B.5.5Fax number+441312006322
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ALM201
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALM201
    D.3.9.2Current sponsor codeALM201
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced ovarian cancer and other solid tumours
    E.1.1.1Medical condition in easily understood language
    Late stage cancer of the ovary and other solid tumours
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to characterise the safety and tolerability of ALM201 (Part 1 and Part 2) and to identify a recommended phase 2 dose (RP2D) and schedule of ALM201 (Part 2 only)
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •To establish the pharmacokinetic profile of ALM201
    •To assess anti-tumour activity
    •To assess anti-tumour activity in a biomarker-enriched group of patients with advanced ovarian cancer (Part 2 only)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (i) Part 1 Specific Inclusion Criterion:
    1.Patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available or felt likely to be of limited efficacy and in whom a rationale for use of an anti-angiogenic treatment approach exists. Note: Previous use of anti-angiogenic therapy is allowed if tolerated.

    (ii) Part 2 Specific Inclusion Criterion:
    2.Patients with advanced ovarian cancer, who are intolerant of or whose tumour is resistant to platinums and who have failed to respond to, or have relapsed following, standard therapy and whose tumour has a proangiogenic profile as assessed by the angiogenesis gene signature test. Note: Previous use of anti-angiogenic therapy is allowed if tolerated.

    (iii) General Inclusion Criteria for all Patients
    3.Adult patients defined by age ≥16 years at time of consent.
    4.Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by RECIST 1.1 or other relevant response assessment criteria for tumour type.
    5.Recovery from previous treatment to baseline or CTCAE ≤ Grade 1, as determined by CTCAE v4.03 criteria of reversible toxicities related to prior treatment, with the exception of alopecia, lymphopenia, other non-clinically significant adverse events; recovery from previous radiotherapy other than residual cutaneous effects or stable < Grade 2 gastrointestinal toxicity; complete recovery from surgery other than stable < Grade 2 toxicity.
    6.Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
    7.Laboratory values at Screening:
    •Absolute neutrophil count ≥1.5 x 10e9/L without colony stimulating factor support;
    •Platelets ≥100 x 10e9/L;
    •Haemoglobin ≥9 g/dL (not transfusion dependent);
    •Total bilirubin <1.5 times the upper limit of normal (ULN) (unless due to Gilbert’s syndrome);
    •AST (SGOT) ≤2.5 times the ULN; ALT (SGPT) ≤2.5 times the ULN; ≤5 x ULN for patients with advanced solid tumours with liver metastases; patients with confirmed bony metastases will be permitted on study with isolated elevations in ALP < 5 times the ULN;
    •Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) of >50 mL/min based on the Cockcroft-Gault formula;
    •Normal coagulation (elevated INR, prothrombin time or APTT ≤ 1.3 x ULN range acceptable);
    •Urine protein ≤2+ (as measured by dipstick).
    8.Negative urine or blood human chorionic gonadotropin (hCG) test during Screening and within 7 days of Cycle 1, Day 1 in women of childbearing potential (defined as women ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to study entry). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, during the entire duration of the study and for 6 months after final administration of ALM201. Note that sterility in female patients must be confirmed in the patients’ medical records and can be defined as any of the following: surgical hysterectomy with bilateral oophorectomy, natural menopause with menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses.
    9.Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
    10.Patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
    E.4Principal exclusion criteria
    1.History of inability to tolerate anti-angiogenic therapies e.g. increased blood pressure (BP), proteinuria, prior thromboembolic events.
    2.Previous history of bowel obstruction, clinical evidence of gastro-intestinal obstruction, large burden of peritoneal disease or evidence of bowel involvement on computed tomography.
    3.Patents has received:
    a) any chemotherapy regimens (including investigational agents) with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle 1, Day 1, or received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of Cycle 1, Day 1.
    b) radiotherapy, immunotherapy or biological agents (includes investigational agents) within 4 weeks of Cycle 1, Day 1. Localised palliative radiotherapy is permitted for symptom control.
    4.Documented, symptomatic or uncontrolled intracranial metastases or primary intracerebral tumours.
    5.Cancer with leptomeningeal involvement.
    6.On therapeutic anti-coagulation (aspirin dosing ≤100 mg per oral (PO) daily allowed).
    7.Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumour was treated with curative intent more than 2 years prior to study entry.
    8.History of clinically significant cardiac condition, including uncontrolled hypertension (BP >140/90 mmHg, despite medical therapy); left ventricular systolic dysfunction (ejection fraction (<55 %) on echocardiography) with or without heart failure symptoms; history of an ischaemic cardiac event within 3 months of study entry (myocardial infarction, acute coronary syndrome); QT interval prolongation (QTcF, Fridericia’s Correction of >450 ms on screening 12-lead ECG); clinically significant cardiac arrhythmia within 3 months of study entry. Note: ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, atrial fibrillation without adequate heart rate control, atrial fibrillation with adequate heart rate control with or without medication or other treatment, are not an exclusion.
    9.Known human immunodeficiency virus positivity.
    10.Active hepatitis B or C or other active liver disease (other than malignancy).
    11.Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day 1.
    12.Any evidence of severe or uncontrolled systemic conditions or any other issues which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    •Ongoing evaluation of AEs during treatment and follow up; evaluation of DLT during Cycle 1 (Part 1 only)
    •Safety, PK, PD and tumour response assessments for identification of RP2D

    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be noted at every clinical visit & recorded at least every week. Evaluation of DLT ongoing throughout Part 1.
    Safety assessed throughout study.
    A PK profile for ALM201 will be taken on Days 1, 3 & 18 of Cycle 1 & on Day 18 of Cycles 2, 4, 6 & 8. Pre-dose samples will also be taken on Cycles 2-8 on Day 1.
    Biopsies for biomarker/PD evaluation will be taken at Screening & up to 2 post-treatment. Up to 12 post-treatment biomarker/PD samples in blood and 2 post-treatment biomarker/PD samples in ascites will be taken.
    Tumour assessment by imaging, or informative markers where relevant, will be assessed at Screening & after every 2 cycles of treatment during Cycles 1–8 & then after every 4 cycles, & may be performed at other times as clinically indicated.

    E.5.2Secondary end point(s)
    •Assessment of pharmacokinetic variables (including Cmax, Cmin, AUC)
    •Tumour response assessment by RECIST 1.1 and/or other relevant response assessments for tumour types enrolled
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will have a 12-hour urine collection on Cycle 1, Day 1 for urine PK analysis.
    Patients will have PK blood sampling conducted at Cycle 1, Day 1; Cycle 1, Day 3 & 18; Cycles 2, 4, 6 & 8, Day 18.
    A single pre-dose sample will also be taken on Cycles 2-8, on Day 1.
    Tumour assessment will follow RECIST 1.1 after every 2 cycles.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS. Patients will continue to be followed up every 8 weeks for up to approximately a 2 year period, to check their disease (survival) status.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Most patients will receive normal standard of care. Patients may be permitted to receive further consecutive cycles of ALM201 where their cancer has not progressed on study and their investigator recommends this course of action, subject to availability of ALM201.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-05-23
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands