Advanced Solid TumorsPhase 1NCT02462707
A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors
A Phase 1 study testing PF-03084014 in people with Advanced Solid Tumors, run by Pfizer.
Trial summary
The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PF-03084014
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2016
- 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
- Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
- Age ≥18 years.
- ECOG Performance Status (PS) must be 0 or 1.
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1
Who cannot join
- Patients with known brain metastases
- Major surgery within 4 weeks of starting study treatment
- Radiation therapy within 2 weeks of starting study treatment
- Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
- Previous high dose chemotherapy requiring stem cell rescue
- Prior irradiation to >25% of the bone marrow
Show all 11Show fewer
- Prior treatment with a Notch signal inhibitor
- Known malabsorption syndrome or other condition that may impair absorption of study medication
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
- Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
- Current use or anticipated need for known strong CYP3A4 inducers
About this study
Official title: Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.
- Conditions
- Advanced Solid Tumors
- Being tested
- PF-03084014
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03084014Drug
gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| PF-03084014 | Experimental | Not described Receives: Drug: PF-03084014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-cycle Dose Limiting Toxicities
Measured: during the first 28 days from the first dose
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
QTc interval
Measured: from the first dose to the last dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Apparent Oral Clearance (CL/F)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Apparent Volume of Distribution at steady state (Vss/F)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Minimum Observed Plasma Trough Concentration (Cmin)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Average Serum Concentration at steady state (Cav)
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Accumulation Ratio (Rac)
Measured: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462707
- Sponsor's protocol ID
- A8641021
- Status last verified
- Aug 2015
- First submitted
- 2 Jun 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02462707
- Acronym / sponsor ID
- A8641021
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 4 Jun 2015 (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.
The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-03084014 | Experimental | Drug: PF-03084014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
- Age ≥18 years.
- ECOG Performance Status (PS) must be 0 or 1.
- Adequate Bone Marrow Function
- Adequate Renal Function
Key exclusion criteria (11 listed)
- Patients with known brain metastases
- Major surgery within 4 weeks of starting study treatment
- Radiation therapy within 2 weeks of starting study treatment
- Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
- Previous high dose chemotherapy requiring stem cell rescue
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 |
|---|---|---|
| PF-03084014gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule | Drug | PF-03084014 |
Primary outcome
First-cycle Dose Limiting Toxicities
Time frame: during the first 28 days from the first dose
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
QTc interval
Time frame: from the first dose to the last dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Apparent Oral Clearance (CL/F)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Apparent Volume of Distribution at steady state (Vss/F)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Average Serum Concentration at steady state (Cav)
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose
Accumulation Ratio (Rac)
Time frame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-03084014 in people with Advanced Solid Tumors, run by Pfizer.
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 7 inclusion and 11 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 7 Oct 2015. 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 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 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?
First-cycle Dose Limiting Toxicities (time frame: during the first 28 days from the first dose). 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 7 Oct 2015.