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Metastatic Colorectal CancerPhase 1/2ALCAPNCT04753203

Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients

A Phase 1/2 study testing Alpelisib plus Capecitabine combination in people with Metastatic Colorectal Cancer and PIK3CA Gene Mutation, run by Korean Cancer Study Group at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigator assesses the efficacy and safety of alpelisib and capecitabine in patients with PIK3CA mutant metastatic colorectal cancer who failed two prior standard chemotherapies. Read more about this study

Who is it for?
Ages 19 to 90 years
What is being tested?
Alpelisib plus Capecitabine combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteSouth Korea
Study dates
28 Feb 2021to 28 Feb 2025
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 19 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed
  • Age ≥ 19 years old of male and female
  • At each phase of the trial, subjects who meet the following requirements in each phase will be enrolled.
  • Phase Ib: Subjects with a histologically-confirmed, advanced/recurrent solid tumor who have progressed on standard therapy or whose disease does not have established standard therapy and not limited to PIK3CA mutation Phase II: Subjects with histologically confirmed, PIK3CA mutated, metastatic colorectal cancer that have progressed after treatment with two prior standard chemotherapeutic agents with targeted agents such as cetuximab, bevacizumab, aflibercept (Tissue samples of colorectal cancer patients must contain just PIK3CA gene alterations. e.g. single nucleotide variants, small indels, amplifications, structural variation etc. using targeted panel sequencing.)
  • Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.)
  • ECOG performance status 0-1
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  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet ≥ 100 x 109/L
  • Serum creatinine ≤ ULN (upper limit of normal) or serum creatinine clearance > 50 mL/min
  • Total bilirubin: ≤ 1.5 × ULN Subjects with a bile duct obstruction will be eligible if they meet the criteria after appropriate bile drainage; Patients with Gilbert syndrome should also be included after confirming that the total bilirubin level is ≤ 1.5 x ULN in a follow-up screening test.
  • INR ≤1.5
  • Potassium within normal limits, or corrected with supplements
  • Fasting Serum amylase ≤ 2 × ULN
  • Fasting Serum lipase ≤ ULN
  • 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

Who cannot join

  • Patient has received previous treatment with a PI3K or AKT inhibitor. (Note prior mTOR inhibitor treatment is allowed.)
  • Patient has received previous capecitabine in metastatic setting.
  • Patient has a known or suspicious hypersensitivity to capecitabine or other products containing fluorouracil.
  • 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 was given, the subject can be enrolled after four weeks after the last does.
  • 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.
  • Patient has currently documented pneumonitis/interstitial lung disease
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  • Patient has not recovered to ≤ grade 1 (except alopecia) from related adverse effects of any prior anticancer 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 clinically significant cardiac disease or impaired cardiac function, such as:
  • 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)
  • 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 >160 mmHg or diastolic >100 mmHg with or without anti-hypertensive medication. 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)
  • On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or corrected QT (QTcF) >450 msec for males and >460 msec for females (using Fridericia's correction). All as determined by screening ECG (mean of triplicate ECGs).
  • 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)
  • If the subject was diagnosed with diabetes (irrespective of treatment or symptom) or if the subject has impaired glucose tolerance (with blood glucose of 140-199 mg/dL after 2 hour oral glucose tolerance test (75g)), previous history of gestational diabetes, or steroid-induced diabetes.
  • Patients with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. untreated peptic ulcer disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or wide small bowel resection).
  • History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
  • 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.)
  • Inhibitors of BCRP
  • Subjects with unresolved osteonecrosis of the jaw
  • Subject has a history of severe cutaneous reactions like Stevens-Johnson-Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
  • 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)
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Anam Hospital

    Seoul, 02841

Other trials in South Korea

About this study

Official title: A Phase lb/ll, Open Label, Single Arm Study to Assess Efficacy and Safety of Alpelisib and Capecitabine in Patients With PIK3CA Mutant Metastatic Colorectal Cancer Who Failed Two Prior Standard Chemotherapies

The investigator assesses the efficacy and safety of alpelisib and capecitabine in patients with PIK3CA mutant metastatic colorectal cancer who failed two prior standard chemotherapies.

Read the detailed description

Phase lb To determine maximal tolerated dose (MTD) and recommended phase ll dose (RP2D) of alpelisib in combination with capecitabine regardless of PIK3CA mutation of any solid tumors

Phase ll To investigate the progression-free survival (PFS)

Conduct the exploratory biomarker analysis for efficacy and resistance of alpelisib plus capecitabine combination (using collected clinical samples)

Being tested
Alpelisib plus Capecitabine combination
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Alpelisib plus Capecitabine combinationDrug

    Adding Alpelisib to Capecitabine as a salvage regimen in mCRC with PIK3CA mutation

Study groups in NCT04753203
Study groupRoleWhat they receive
A single arm study with Alpelisib plus CapecitabineExperimentalA phase lb/ll, open label, single arm study with Alpelisib plus Capecitabine in patients with PIK3CA mutant metastatic colorectal cancer
Receives: Drug: Alpelisib plus Capecitabine combination

What is being measured

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

  1. Maximal tolerable dose

    Maxiaml Tolerable Dose and Recommended Phase 2 Dose of combination Maximal tolerable dose and random phase 2 dose confirmation in Alpelisib with Capecitabine in phase 1b

    Measured: up to 6 month

  2. Progression Free Survival

    Progression Free Survival with RP2D dose

    Measured: up to 3 years

Secondary outcomes (5)

  1. Dose limiting toxicity

    Dose limiting toxicity

    Measured: Up to 6 month

  2. Objective response rate

    Objective response rate (by RECIST v1.1)

    Measured: up to 3 years

  3. Overall survival

    Overall survival

    Measured: up to 4 years

  4. Time to response

    Time to response

    Measured: up to 3 years

  5. Duration of response

    Duration of response

    Measured: up to 3 years

Timeline

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

  1. First posted15 Feb 2021
  2. Study start28 Feb 2021
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

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
Model description
A phase lb/ll, open label, single arm study
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753203
Sponsor's protocol ID
K2020-2011-003
Acronym
ALCAP
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
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alpelisib plus Capecitabine combination in people with Metastatic Colorectal Cancer and PIK3CA Gene Mutation, run by Korean Cancer Study Group at 1 site in South Korea.

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 22 inclusion and 30 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: status not confirmed, 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.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Results are not available in the source record.

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 tolerable dose (time frame: 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 NCT04753203.

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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