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Colorectal Cancer MetastaticPhase 1/2NCT04751955

A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP)

A Phase 1/2 study testing Olinvacimab added to Capecitabine in people with Colorectal Cancer Metastatic, run by Korean Cancer Study Group.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim on this study is to assess the safety and efficacy of the anti-VEGFR2 monoclonal antibody olinvacimab and the capecitabine in patients with metastatic colorectal carcinoma who failed two prior chemotherapies Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Olinvacimab added to Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 31 Aug 2024
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

  • Phase Ib: Subjects with a histologically-confirmed, advanced/recurrent colorectal cancer who have progressed on two prior standard chemotherapies Phase II: Histologically or cytologically confirmed colorectal cancer patient who had progressed on, were intolerant of, or were inappropriate for the treatment with fluoropyrimidine, oxaliplatin, irinotecan and targeted agents (If the subject received adjuvant chemotherapy after curative surgery and lymph node dissection for colorectal cancer, the adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.)
  • Permit previous 2 lines of anti-VEGF blockades
  • Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.)
  • Age ≥ 19 years old of male and female
  • ECOG performance status (PS) 0-1
  • Adequate bone marrow and organ function as defined by the following laboratory values:
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  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet ≥ 75 x 109/L
  • Serum creatinine ≤ ULN (upper limit of normal) x 1.5 or serum creatinine clearance > 30 mL/min
  • Total bilirubin: ≤ 2.0 × ULN, Subjects with a bile duct obstruction will be eligible if they meet the criteria after appropriate bile drainage
  • Phase Ib: Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 3 x ULN (regardless of liver metastases)
  • Phase II: AST and ALT ≤ 3 x ULN if liver metastases are absent, or AST and ALT ≤ 5 x ULN if liver metastases are present.
  • Adequate cardiac function: QTc ≤480 msec; if QTc exceeds 480 msec, subjects can be enrolled if the average QTc value is less than 480 msec by measuring 3 times consecutively in total.
  • The subject is able to swallow and retain oral medication
  • Serum β-HCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only).
  • Requirement for contraception must be observed by the subject.
  • Life expectancy of at least 3 months
  • Subject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed.

Who cannot join

  • Patient has a known or suspicious hypersensitivity to fluoropyrimidines.
  • Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subject can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy including anti VEGF agent was given, the subject can be enrolled after four weeks after the last does.
  • Patients with complete or partial dihydropyrimidine dehydrogenase deficiency.
  • Serious uncontrolled intercurrent infections
  • Serious intercurrent medical or psychiatric illness, including active cardiac disease
  • Acute coronary syndrome within the 6 months prior to the initiation of study drug (including myocardial infarction or unstable angina, Coronary Artery Bypass Graft surgery, percutaneous coronary intervention and stenting)
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  • Heart failure ≥ grade 2 by New York Heart Association (NYHA) functional classification or that requires treatment
  • Ejection fraction (EF) <50% on multi-gated acquisition (MUGA) scan or echocardiography examination. MUGA scan or echocardiography is not required as a screening test if there is no current suspicious symptom and past history of heart failure.
  • Persistent uncontrolled hypertension as defined by: systolic >180 mmHg or diastolic >100 mmHg despite medical treatment. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.
  • Current or past history of clinically significant cardiac arrhythmia, atrial fibrillation, and/or conduction abnormality (e.g. congenital long QT syndrome, complete AV block)
  • Any risk factors that prolong QTc or increase the probability of arrhythmia, including medication (e.g. heart failure, hypokalemia, congenital long QT syndrome, history of Torsades de Pointes)
  • Active central nervous system (CNS) lesions (i.e., those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without steroid therapy and the evidence of CNS disease progression for more than 4 weeks. However, patients with leptomeningeal metastases are excluded.
  • History of other primary cancer. Exceptions are as follows:
  • Adequately treated non-melanoma skin cancer (basal cell or squamous cell carcinoma), curatively treated in situ cancer of the cervix or stage I bladder cancer, completely resected thyroid cancer without distant metastasis in which all treatment has been completed (Appropriate wound healing is required prior to clinical trial enrollment)
  • Other curatively treated solid tumors except for gastric cancer with no evidence of disease recurrence at least 36 months before participating in this trial
  • Patient has not recovered to ≤ grade 1 (except alopecia) from related adverse effects of any prior antineoplastic therapy.
  • Radiotherapy with a wide field (more than 30% of the bone marrow) of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
  • Patient who has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from adverse effects of such procedure.
  • Patient has a known positive serology for human immunodeficiency virus (HIV), active Hepatitis B, and/or active Hepatitis C infection. Hepatitis B carriers may be enrolled if prophylactic use of an antiviral agent with minimal interaction with CYP3A4 is administered to inhibit HBV activation (e.g., entecavir, adefovir)
  • Concomitant medication of strong or moderate inducers or inhibitors of CYP3A4 before the first dose of study treatment (In this case, if the drug is stopped for more than 1 week and changed to another drug that does not affect CYP3A4, then the subject can be enrolled.)
  • People who are taking BCRP inhibitors, allopurinol, soribudin, brivudine or within 4 weeks of stopping, and taking tegafur/gimeracil/oteracil or within 7 days of stopping
  • History of allogeneic bone marrow transplantation or organ transplantation
  • As judged by the Investigator, all other symptoms and associated disease for which the investigator determined that participation in this study is contraindicated (e.g. Infection/inflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; unable to swallow oral pills; social and psychological problems, etc.)
  • Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial

About this study

Official title: A Phase lb/ll, Multicenter, Open Label, Single Arm Study to Assess the Safety and Efficacy of the Anti-VEGFR2 Monoclonal Antibody Olinvacimab and the Capecitabine in Patients With mCRC Who Failed Two Prior Chemotherapies

The aim on this study is to assess the safety and efficacy of the anti-VEGFR2 monoclonal antibody olinvacimab and the capecitabine in patients with metastatic colorectal carcinoma who failed two prior chemotherapies

Read the detailed description

This is a phase lb/ll, multicenter, open label, single arm study to assess efficacy and safety of the anti-VEGFR2 monoclonal antibody olinvacimab and capecitabine in patients with metastatic colorectal cancer who failed two prior standard chemotherapies.

The primary objective of phase lb is to determine maximal tolerated dose (MTD) and recommended phase ll dose (RP2D) of olinvacimab in combination with capecitabine. the primary objective of phase ll is to assess the efficacy of olinvacimab plus capecitabine as a salvage regimen in metastatic colorectal carcinoma.

Being tested
Olinvacimab added to Capecitabine

What participants receive

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

  • Olinvacimab added to CapecitabineDrug

    Also called Capecitabine

    Olinvacimab: IV weekly administration In phase lb, 12mg/kg and 16mg/kg weekly IV will be tested. In phase ll, the RP2D in phase lb will be used. Capecitabine: fixed dose as an oral administration, 1250mg/m2 BID on day 1 to 14 followed by 7 days off

Study groups in NCT04751955
Study groupRoleWhat they receive
Olinvacimab plus CapecitabineExperimentalA single arm study with Olinvacimab plus Capecitabine
Receives: Drug: Olinvacimab added to Capecitabine

What is being measured

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

  1. Maximal tolerated dose (MTD)

    recommended phase ll dose (RP2D) of olinvacimab in combination with capecitabine

    Measured: Through phase 1b, up to 6 month

  2. Progression free survival

    Progression free survival of olinvacimab plus capecitabinel

    Measured: 3 years

Secondary outcomes (7)

  1. Objective response rate (ORR)

    Determination of the ORR will be calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 as assessed by investigators.

    Measured: 2 years

  2. overall survival

    overall survival

    Measured: 3 years

  3. Disease control rate (DCR)

    DCR will be calculated based on the proportion of patients achieving CR, PR, or who have SD at least 6 weeks after receiving first dose of study treatment.

    Measured: 2 years

  4. Duration of response (DOR)

    DOR will be calculated from the time of initial response (CR or PR) documentation to the time of progressive disease (PD). If a subject who had CR or PR dies without the evidence of disease progression, the case will be censored at the time point of death when analyzing DOR

    Measured: 2 years

  5. Time to response (TTR)

    Time to response (TTR) will be calculated from the first dose of study drug to the time point of initial response (CR or PR).

    Measured: 2 years

  6. Toxicity by CTCAE v5.0

    Safety assessments should be conducted for all subjects who received olinvacimab plus capecitabine at least once. Adverse events will be graded according to CTCAE v5.0.

    Measured: 3 years

  7. Quality of life by FACT-C v4.0

    Quality of life as measured by FACT-C v4.0

    Measured: 2 years

Timeline

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

  1. First posted12 Feb 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Why it stopped: This clinical trial was not finally approved by the Korea FDA.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751955
Sponsor's protocol ID
OLCAP
Status last verified
Oct 2023
First submitted
4 Feb 2021
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Olinvacimab added to Capecitabine in people with Colorectal Cancer Metastatic, run by Korean Cancer Study Group.

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 19 inclusion and 24 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: withdrawn, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Maximal tolerated dose (MTD) (time frame: Through phase 1b, up to 6 month). The study lists 2 primary outcomes in all. 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 NCT04751955.

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 31 Oct 2023.

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