Solid TumourPhase 1NCT01219543
A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.
A Phase 1 study testing AZD1480 Daily and AZD1480 BID in people with Solid Tumour and Advanced Solid Malignancies, run by AstraZeneca at 1 site in South Korea.
Trial summary
This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumour, Advanced Solid Malignancies, Child-Pugh A to B7 Advanced Hepatocellular Carcinoma
- What is being tested?
- AZD1480 Daily and AZD1480 BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Dec 2012
- 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
- Male or female aged 18 years or older
- For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
- For Expansion : Histological or cytological confirmation of
- Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis
- Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
- For Part B : Advanced or metastatic HCC, unresectable and incurable with ablative therapy or TACE, with no standard therapy available.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks
- For Part B : Child-Pugh liver function status classified as A to B7
Who cannot join
- For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter.
- With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study)
- Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation
- Inadequate bone marrow reserve or organ function as demonstrated by laboratory values
- Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 in Asian Patients With Advanced Solid Malignancies and Asian Patients With Child-Pugh A to B7 Advanced Hepatocellular Carcinoma (HCC) in the Escalation Phase, Estimated Glomerular Filtration Rate(EGFR) or ROS Mutant NSCLC and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour With Biopsy Available in the Expansion Phase.
This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.
- Conditions
- Solid Tumour, Advanced Solid Malignancies, Child-Pugh A to B7 Advanced Hepatocellular Carcinoma, EGFR and/or ROS Mutant NSCLC, Lung Metastasis Carcinoma, Gastric Cancer
- Being tested
- AZD1480 Daily, AZD1480 BID
- Keywords
- Advanced solid malignancies, Child-Pugh A to B7 advanced hepatocellular carcinoma, EGFR and/or ROS mutant NSCLC, Non-smokers with lung metastasis, Gastric cancer, Solid tumour, AZD1480, JAK1/JAK2 kinase inhibitor
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1480 DailyDrug
Oral Dose, Capsule, Daily Dosing
AZD1480 BIDDrug
Oral Dose, Capsule, BID Dosing
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Daily dosing of AZD1480 to the patients with solid tumours excluding HCC Receives: Drug: AZD1480 Daily |
| Part B | Experimental | BID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7) Receives: Drug: AZD1480 BID |
| Part C | Experimental | BID dosing of AZD1480 to the patients with solid tumours excluding HCC Receives: Drug: AZD1480 BID |
| Expansion | Experimental | BID dosing of AZD1480 to the patients with EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer and solid tumour with biopsy available. Receives: Drug: AZD1480 BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of AZD1480
Measured: Safety and tolerability monitoring will proceed for whole study period. Screening, Cycle1Day1, Cycle1Day5 (only for Part B), Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8 and Day1 of further Cycles, IP discontinued visit and 30-days follow up
Secondary outcomes (2)
To evaluate the pharmacokinetics (PK) of AZD1480 following single dose and multiple doses
Measured: Part A and Expansion - 12 times during Cycle 1, 11 times during Cycle 2. Part B and C - 11 times during Cycle 1, 10 times during Cycle 2. *1 additional PK sample in Cycle 1 will be collect for optional biopsy sample collected patients.
To obtain a preliminary assessment of the anti-tumour activity of AZD1480
Measured: Tumour response assessment by RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Compound development discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumourStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Becker Hewes, MD, Study director, AstraZenecaKang Yoon-Koo, MD, PhD, Principal investigator, Asian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219543
- Sponsor's protocol ID
- D1060C00004
- Status last verified
- Jan 2013
- First submitted
- 11 Oct 2010
- Last updated
- 8 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 in Asian Patients With Advanced Solid Malignancies and Asian Patients With Child-Pugh A to B7 Advanced Hepatocellular Carcinoma (HCC) in the Escalation Phase, Estimated Glomerular Filtration Rate(EGFR) or ROS Mutant NSCLC and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour With Biopsy Available in the Expansion Phase.
- ClinicalTrials.gov ID
- NCT01219543
- Acronym / sponsor ID
- D1060C00004
- Conditions
- Solid Tumour, Advanced Solid Malignancies, Child-Pugh A to B7 Advanced Hepatocellular Carcinoma, EGFR and/or ROS Mutant NSCLC, Lung Metastasis Carcinoma, Gastric Cancer
- Keywords
- Advanced solid malignancies, Child-Pugh A to B7 advanced hepatocellular carcinoma, EGFR and/or ROS mutant NSCLC, Non-smokers with lung metastasis, Gastric cancer, Solid tumour, AZD1480, JAK1/JAK2 kinase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Compound development discontinued
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: AZD1480 DailyDaily dosing of AZD1480 to the patients with solid tumours excluding HCC |
| Part B | Experimental | Drug: AZD1480 BIDBID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7) |
| Part C | Experimental | Drug: AZD1480 BIDBID dosing of AZD1480 to the patients with solid tumours excluding HCC |
| Expansion | Experimental | Drug: AZD1480 BIDBID dosing of AZD1480 to the patients with EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer and solid tumour with biopsy available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 years or older
- For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
- For Expansion : Histological or cytological confirmation of
- Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis
- Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma \& HCC are excluded.
Key exclusion criteria (5 listed)
- For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter.
- With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study)
- Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation
- Inadequate bone marrow reserve or organ function as demonstrated by laboratory values
- Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1480 DailyOral Dose, Capsule, Daily Dosing | Drug | Part A |
| AZD1480 BIDOral Dose, Capsule, BID Dosing | Drug | Expansion, Part B, Part C |
Primary outcome
To investigate the safety and tolerability of AZD1480
Time frame: Safety and tolerability monitoring will proceed for whole study period. Screening, Cycle1Day1, Cycle1Day5 (only for Part B), Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8 and Day1 of further Cycles, IP discontinued visit and 30-days follow up
2 secondary outcomes
To evaluate the pharmacokinetics (PK) of AZD1480 following single dose and multiple doses
Time frame: Part A and Expansion - 12 times during Cycle 1, 11 times during Cycle 2. Part B and C - 11 times during Cycle 1, 10 times during Cycle 2. *1 additional PK sample in Cycle 1 will be collect for optional biopsy sample collected patients.
To obtain a preliminary assessment of the anti-tumour activity of AZD1480
Time frame: Tumour response assessment by RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 every 6 weeks
Results and safety
The study was stopped early (reason given: Compound development discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becker Hewes, MD study director
AstraZeneca
Kang Yoon-Koo, MD, PhD principal investigator
Asian Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1480 Daily and AZD1480 BID in people with Solid Tumour and Advanced Solid Malignancies, run by AstraZeneca 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Jan 2013. 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 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 was stopped early (reason given: Compound development discontinued). 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?
To investigate the safety and tolerability of AZD1480 (time frame: Safety and tolerability monitoring will proceed for whole study period. Screening, Cycle1Day1, Cycle1Day5 (only for Part B), Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8 and Day1 of further Cycles, IP discontinued visit and 30-days follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2013.