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Advanced Solid TumoursPhase 1NCT04742036

Capivasertib China PK Study

A Phase 1 study testing Capivasertib and Paclitaxel in people with Advanced Solid Tumours, run by AstraZeneca at 1 site in China.

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

This is an open-label, 2-part Phase I study to assess the PK, safety and tolerability of capivasertib as monotherapy and in combination with paclitaxel in Chinese participants with advanced solid tumours Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Advanced Solid Tumours
What is being tested?
Capivasertib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
22 Feb 2021to 29 Jul 2022
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 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computer tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements, or Lytic or mixed (lytic + sclerotic) bone lesions that can be assessed by CT or MRI in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
  • Histologically or, where appropriate, cytologically-confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists
  • Participants must have a life expectancy of ≥12 weeks
  • Participants must be eligible for paclitaxel treatment as per local investigator assessment
  • ECOG performance status 0-1
  • Participants must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of capivasertib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of capivasertib dosing

Who cannot join

  • Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment
  • Other malignancies within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
  • Participants with any ongoing toxicities (>CTCAE grade 2), with the exception of alopecia, caused by previous cancer therapy
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
  • Any of the following cardiac criteria at screening:
  • Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs
Show all 19Show fewer
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block)
  • Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:
  • Participants with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment
  • glycosylated haemoglobin (HbA1c) ≥8.0% (63.9 mmol/mol)
  • Inadequate bone marrow reserve or organ function
  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
  • Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
  • Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
  • Previous allogeneic bone marrow transplant or solid organ transplant
  • Evidence of dementia-altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent
  • Any previous treatment with AKT, PI3K, and/or mTOR inhibitors
  • Participation in another clinical study with an IP administered in the last 30 days or 5 half-lives, whichever is longer.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Research Site

    Shanghai, 200032

Other trials in China

About this study

Official title: A Phase I Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Capivasertib Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours.

This is an open-label, 2-part Phase I study to assess the PK, safety and tolerability of capivasertib as monotherapy and in combination with paclitaxel in Chinese participants with advanced solid tumours

Read the detailed description

A Phase I study is designed to assess the PK, safety and tolerability of single-dose and multiple-dose capivasertib as monotherapy (Part A) and in combination with paclitaxel (Part B) in approximately 16 Chinese participants with advanced solid tumours and to detect any differences in the PK profile between Chinese and Caucasian participants due to ethnicity. Descriptive summary will be conducted on the PK analysis set and safety analysis set.The evaluation of capivasertib PK data will be based on the PK analysis set.The assessment on safety and tolerability will be based on the safety analysis set.

Being tested
Capivasertib, Paclitaxel
Keywords
Pharmacokinetics, Safety, Tolerability, Capivasertib, Chinese

What participants receive

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

  • CapivasertibDrug

    Also called AZD5363

    Part A Cycle 0: Single dose 480 mg(3 x 160 mg tablets) on Day 1 of Cycle 0 Cycle 1 (monotherapy): 480 mg(3 x 160 mg tablets) twice daily given on an intermittent weekly dosing schedule (4 days on, 3 days off for 7 days) Part B Cycle 2 (in combination therapy with paclitaxel): 400 mg (2 x 200 mg tablets) twice daily given on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib treatment will continue until disease progression, unacceptable toxicity or the participant requests to stop treatment.

  • PaclitaxelDrug

    Part B Cycle 2: Patients will receive 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.

    Paclitaxel treatment will continue for at least 6 cycles, unless the participant experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel, or disease progression.

Study groups in NCT04742036
Study groupRoleWhat they receive
capivasertibExperimentalsingle-dose and multiple-dose capivasertib as monotherapy (Part A) and then in combination with paclitaxel (Part B)
Receives: Drug: Capivasertib; Drug: Paclitaxel

What is being measured

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

  1. Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC 0-12) of Capivasertib

    AUC0-12 is defined as area under the curve from 0 to 12 hours.

    Measured: first dose up to approximately 6 months

  2. Maximum plasma concentration (Cmax) of Capivasertib

    Cmax is defined as maximum plasma concentration

    Measured: first dose up to approximately 6 months

  3. terminal half-life (t1/2) of Capivasertib

    t1/2 is defined as terminal half-life

    Measured: first dose up to approximately 6 months

  4. Accumulation ratio (Rac) of Capivasertib

    Rac is defined as accumulation ratio

    Measured: first dose up to approximately 6 months

Secondary outcomes (1)

  1. Safety and tolerability of drugs by assessment of AEs/SAEs

    Graded according to the National Cancer Institute (NCI CTCAE V5.0)

    Measured: From time of signature of the ICF, through study completion, up to 17 months, and including the 30-day follow-up period after discontinuation of study drug

Timeline

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

  1. First posted5 Feb 2021
  2. Study start22 Feb 2021
  3. Primary completion29 Jul 2022
  4. Study completion29 Jul 2022

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742036
Sponsor's protocol ID
D3614C00002
Status last verified
Aug 2022
First submitted
15 Jan 2021
Last updated
19 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

  • Zhang J, Liu X, Du Y, Mu Y, Meng Y, Sun Y, Zhang L, Chen C, Cullberg M, Fan E, Hu X. A Phase I open-label study to assess the pharmacokinetics, safety, and tolerability of capivasertib alone or in combination with paclitaxel in Chinese patients with advanced solid tumors. BMC Cancer. 2025 Oct 14;25(1):1562. doi: 10.1186/s12885-025-14982-4.

    PubMed 41088025

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capivasertib and Paclitaxel in people with Advanced Solid Tumours, run by AstraZeneca at 1 site in China.

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 6 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 19 Aug 2022. 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 China. 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?

Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC 0-12) of Capivasertib (time frame: first dose up to approximately 6 months). The study lists 4 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 NCT04742036, which also lists 1 linked publication.

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 19 Aug 2022.

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