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CancerPhase 1NCT02719977

A Phase I Study of CX5461

A Phase 1 study testing CX5461 in people with Cancer, run by Canadian Cancer Trials Group at 3 sites in Canada.

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

CX5461 is a new type of drug for many types of cancer, particularly cancers that cannot easily repair damage to their cells. This may help to slow down the growth of cancer or may cause cancer cells to die. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
CX5461
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesCanada
Study dates
13 Jun 2016to 18 Jan 2023
Phase
Phase 1
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

  • Tumour Type Phase I Escalation: Patients must have histologically/and or cytologically confirmed solid malignancy that is advanced/metastatic/recurrent or unresectable and for which no curative therapy exists.
  • Phase I Expansion: Patients must have metastatic/recurrent/locally advanced/unresectable breast cancer with known BRCA1/2 or HRD germline aberrations.
  • All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block. All patients must also have provided informed consent for a whole blood sample (after implementation of amendment 3).
  • All patients enrolled after the implementation of Amendment 2 must also have provided informed consent for, and be willing to undergo, a skin biopsy (of an area including hair follicles, that is not sun-exposed) prior to treatment (after registration) and after cycle 1 day 15 (C1D16). Paired tumour biopsies will also be required for 6-8 patients enrolled to the RP2D expansion. Note: During accrual to this portion of the study, it may be necessary to restrict accrual to patients who are suitable for, and have consented to, tumour and skin biopsies. Paired tumour biopsies are strongly recommended for all patients
  • Patients must be ≥ 18 years of age.
  • Patients must have an ECOG performance status of 0, 1, or 2.
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  • Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).
  • Phase I: patients do not need to have measurable disease
  • Phase I Expansion: patients must have measurable disease
  • Previous Therapy
  • Cytotoxic Chemotherapy:
  • Phase I: There is no limit to the number of prior regimens received.
  • Phase I Expansion: Patients must have received at least one but no more than 3 regimens for advanced disease (Note: adjuvant anthracycline/taxane containing chemotherapy is considered an advanced regimen) Note: initially, there is no limitation to the use of prior platinumor PARPi containing regimens. During the expansion accrual may be limited to patients considered to be platinum naive, or platinum sensitive (no evidence of disease progression on or within 3 months of the last dose) or PARPi naïve or exposed. Sites will be informed at the time of the opening of the cohorts
  • Other Systemic Therapy:
  • There is no limit to the number of prior therapies.
  • Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:
  • Longest of one of the following:
  • Two weeks,
  • 5 half-lives for investigational agents,
  • Standard cycle length of standard therapies.
  • Radiation:
  • Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of registration. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted.
  • Surgery:
  • Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred.
  • Lab Requirements Absolute neutrophils: ≥ 1.5 x 10^9/L Platelets: ≥ 100 x 10^9/L Bilirubin: ≤ 1.5 x ULN (upper limit of normal) AST/ALT: ≤ 2.5 x ULN ≤ 5.0 x ULN if patient has liver metastases Serum creatinine: ≤ 1.25 x ULN Creatinine clearance: ≥ 50 mL/min
  • Women/men of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of CX5461.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
  • Patients must be accessible for treatment and follow up.
  • Treatment is to begin within 2 working days of patient registration.

Who cannot join

  • Other Malignancies
  • Phase I - Patients with other malignancies requiring concurrent anticancer therapy.
  • Phase I Expansion - Patients with a history of other malignancies, except:
  • adequately treated non-melanomatous skin cancer,
  • curatively treated in-situ cancer, or
  • other solid tumours curatively treated at least 2 years prior to registration with no evidence of disease and not requiring concurrent anticancer treatment.
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  • Patients with symptomatic brain metastases or spinal cord compression. Patients with asymptomatic brain/spinal cord metastasis who are not planned for radiation, or who have been treated and are stable off steroids (or on a decreasing dose) and anticonvulsants are eligible.
  • History of hypersensitivity to CX5461 or any excipient.
  • Patients with known photosensitivity disorders (xeroderma pigmentosa, porphyria etc). Patients who do not agree to use sunglasses and sun blocker (with SPF >30 to UVB and a high degree of protection against UVA) if exposed to sunlight during the course of the study and for 3 months after the last dose. Patients who plan to use sun beds or tanning booths during the course of the study and within 3 months after the last dose are not eligible.
  • Patients who have untreated and/or uncontrolled cardiovascular conditions documented within the last year:
  • unstable angina,
  • congestive heart failure,
  • myocardial infarction,
  • cardiac ventricular arrhythmias requiring medication,
  • history of 2nd or 3rd degree atrioventricular conduction defects.
  • Patients who do not have untreated or uncontrolled cardiovascular conditions within the last year must have a LVEF ≥ 50%.
  • Concurrent treatment with other investigational drugs or anti-cancer therapy.
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • Pregnant or lactating women.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

CX5461 is a new type of drug for many types of cancer, particularly cancers that cannot easily repair damage to their cells. This may help to slow down the growth of cancer or may cause cancer cells to die. CX5461 has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment.

Read the detailed description

The purpose of this study is to find the dose of a new therapy, CX5461, that can be tolerated without causing very severe side effects and to see what effects the study drug has this cancer. Participants are given CX5461 and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If serious side effects are seen in patients at the first dose level, doses of CX5461 may be lowered in subsequent patients. If the side effects are not serious, then more participants are asked to join this study and are given higher doses. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Conditions
Cancer
Being tested
CX5461
Medical subject headings
Neoplasms

What participants receive

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

  • CX5461Drug

Study groups in NCT02719977
Study groupRoleWhat they receive
CX-5461ExperimentalCX5461 as intravenous infusion on day 1 and day 8 every 4 weeks. A day 1 every 3 weeks schedule may be used if the day 1 and day 8 every 4 weeks schedule is not tolerable
Receives: Drug: CX5461

What is being measured

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

  1. Confirm the recommended phase II dose and schedule of CX5461 in patients with solid tumours

    Measured: 12 months

Secondary outcomes (2)

  1. Number and severity of adverse events in patients

    To establish the safety and tolerability of CX5461 given intravenously to patients with solid tumours.

    Measured: 12 months

  2. Assess pharmacokinetics of CX5461

    To determine the pharmacokinetics of CX5461 given intravenously to patients with solid tumours

    Measured: 12 months

Timeline

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

  1. First posted25 Mar 2016 (estimated)
  2. Study start13 Jun 2016
  3. Primary completion30 Jan 2020
  4. Study completion18 Jan 2023

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719977
Sponsor's protocol ID
I231
Status last verified
Jan 2023
First submitted
21 Mar 2016
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hilton J, Gelmon K, Bedard PL, Tu D, Xu H, Tinker AV, Goodwin R, Laurie SA, Jonker D, Hansen AR, Veitch ZW, Renouf DJ, Hagerman L, Lui H, Chen B, Kellar D, Li I, Lee SE, Kono T, Cheng BYC, Yap D, Lai D, Beatty S, Soong J, Pritchard KI, Soria-Bretones I, Chen E, Feilotter H, Rushton M, Seymour L, Aparicio S, Cescon DW. Results of the phase I CCTG IND.231 trial of CX-5461 in patients with advanced solid tumors enriched for DNA-repair deficiencies. Nat Commun. 2022 Jun 24;13(1):3607. doi: 10.1038/s41467-022-31199-2.

    PubMed 35750695

  • Xu H, Di Antonio M, McKinney S, Mathew V, Ho B, O'Neil NJ, Santos ND, Silvester J, Wei V, Garcia J, Kabeer F, Lai D, Soriano P, Banath J, Chiu DS, Yap D, Le DD, Ye FB, Zhang A, Thu K, Soong J, Lin SC, Tsai AH, Osako T, Algara T, Saunders DN, Wong J, Xian J, Bally MB, Brenton JD, Brown GW, Shah SP, Cescon D, Mak TW, Caldas C, Stirling PC, Hieter P, Balasubramanian S, Aparicio S. CX-5461 is a DNA G-quadruplex stabilizer with selective lethality in BRCA1/2 deficient tumours. Nat Commun. 2017 Feb 17;8:14432. doi: 10.1038/ncomms14432.

    PubMed 28211448

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CX5461 in people with Cancer, run by Canadian Cancer Trials Group at 3 sites in Canada.

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 29 inclusion and 19 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 4 Aug 2023. 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 Canada. 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 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.

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?

Confirm the recommended phase II dose and schedule of CX5461 in patients with solid tumours (time frame: 12 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 NCT02719977, which also lists 2 linked publications.

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 4 Aug 2023.

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A Phase I Study of CX5461 (NCT02719977) | AzTrials