Solid TumorsPhase 1NCT02038673
An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
A Phase 1 study testing ASP5878 in people with Solid Tumors, run by Astellas Pharma Inc at 35 sites in 4 countries.
Trial summary
The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ASP5878
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 5 Nov 2013to 19 Jul 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumor.
- Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator:
- Disease progression despite standard therapies
- Progressive disease without any standard therapies established
- Standard therapies are considered intolerable
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Predicted life expectancy ≥ 12 weeks in the judgment of the investigator or sub-investigator.
Who cannot join
- Participant with ≥ Grade 2 (CTCAE v 4.0-JCOG) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia).
- Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing).
- A major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study.
- Participant who were treated with other investigational drug or medical device within 4 weeks prior to the planned first day of study drug dosing.
- Participant who has a history of organ transplantation.
- Participant with a brain metastasis with symptoms or requiring treatment.
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
Japan22 sites
Site JP122
Chiba
Site JP108
Fukuoka
Site JP115
Fukuoka
Site JP120
Fukuoka
Site JP116
Hokkaido
Site JP113
Hyōgo
Site JP103
Ibaraki
Site JP111
Ishikawa
Site JP119
Kanagawa
Site JP101
Kyoto
Site JP109
Miyagi
Site JP110
Miyagi
Site JP112
Nagoya
Site JP117
Niigata
Site JP121
Okayama
Site JP104
Osaka
Site JP106
Osaka
Site JP118
Osaka
Site JP124
Shizuoka
Site JP102
Tokyo
Site JP107
Tokyo
Site JP123
Tokyo
United States6 sites
Site US404
Cleveland, Ohio, 44106
Site US410
Fairfax, Virginia, 22031
Site US401
New York, New York, 10032
Site US402
Orange, California, 92868
Site US403
Seattle, Washington, 98109
Site US406
Spartanburg, South Carolina, 29303
South Korea4 sites
Site KR202
Gyeonggi-do
Site KR201
Seoul
Site KR203
Seoul
Site KR204
Seoul
About this study
Official title: An Open-label Phase I Study of Oral ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors.
Read the detailed description
This study consists of two parts. In the dose-escalation part, ASP5878 (orally available novel small-molecule FGFR 1,2,3 and 4 inhibitor, multiple dosing once-a-day (q.d.), multiple dosing twice-a-day (b.i.d.) or 5-day on/2-day off dosing twice-a-day (5on-2off)) is administered to participants with solid tumors in an increasing dose manner, and the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ASP5878 are evaluated in these participants. Cycle 0 consists of 3 days and Cycle 1 and subsequent cycles consist of 28 days each in the dose-escalation part. In the expansion part, 16mg twice-a-day 5-day on/2-day off dose of ASP5878 (5on-2off) is administered to participants with solid tumors and safety, PK, PD and efficacy of ASP5878 are evaluated. The expansion part starts from Cycle 1 and each cycle consists of 28 days.
- Conditions
- Solid Tumors
- Being tested
- ASP5878
- Keywords
- ASP5878, FGFR 1,2,3 and 4 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP5878Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation part 0.5 mg QD | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 1.0 mg QD | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 2.0 mg QD | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 2.0 mg BID | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 4.0 mg BID | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 6.0 mg BID | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 10.0 mg BID | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 20.0 mg BID | Experimental | Oral Receives: Drug: ASP5878 |
| Dose escalation part 16.0 mg BID | Experimental | Oral Receives: Drug: ASP5878 |
| Expansion part Urothelial Carcinoma | Experimental | Oral Receives: Drug: ASP5878 |
| Expansion part Hepatocellular Carcinoma | Experimental | Oral Receives: Drug: ASP5878 |
| Expansion part Squamous Cell Lung Carcinoma | Experimental | Oral Receives: Drug: ASP5878 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-escalation part and Expansion part: Safety assessed by Adverse Events (AEs)
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part:Safety assessed by Vital signs
Blood pressure, pulse rate and body temperature, Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part:Safety assessed by Body weight
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part:Safety assessed by Laboratory tests
Hematology, blood biochemistry, blood coagulation tests and urinalysis, until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part:Safety assessed by 12-lead ECGs
ECG: Electrocardiogram, until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part: Ophthalmology
Eyesight, funduscopy, slit lamp microscopy, and Optical Coherence Tomography, until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part: Bone density measurement
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Dose-escalation part and Expansion part: Computed tomography (CT) Imaging assessment
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Expansion part only: Echocardiogram
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Secondary outcomes (33)
Dose-escalation part: Pharmacokinetics (PK) parameter of ASP5878 in plasma: Cmax
Cmax: Maximum concentration, Cycle 0: single dose, Cycle 1: multiple dose after Cycle 0
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part:PK parameter of ASP5878 in plasma: tmax
tmax: Time of Cmax
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part:PK parameter of ASP5878 in plasma: AUClast
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: t1/2
t1/2: Terminal elimination half-life
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: CL/F
CL/F: Apparent total systemic clearance
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in urine: Ae
Ae: Amount of ASP5878 excreted into the urine
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in urine: CLR
CLR: Renal clearance
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: Pharmacodynamic (PD) parameter: Serum FGF23 concentrations
FGF: Fibroblast Growth Factor
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum inorganic phosphorus concentrations
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum calcium concentrations
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum iPTH concentrations
iPTH: Intact Parathyroid Hormone
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum calcitriol concentrations
Measured: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: Cmax
Measured: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: tmax
Measured: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: AUClast
Measured: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: AUCinf
Measured: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: t1/2
Measured: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: CL/F
Measured: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: Vz/F
Measured: Day 1 and 5 at Cycle 1
Expansion part: PD parameter: Serum FGF19 concentrations
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Expansion part: PD parameter: Serum FGF23 concentrations
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Expansion part: PD parameter: Serum inorganic phosphorus concentrations
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Expansion part: PD parameter: Serum iPTH concentrations
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Expansion part: PD parameter: Serum calcitriol concentrations
Until one of the discontinuation criteria is met.
Measured: Up to 18 months
Expansion part: PD parameter: Serum 7α-hydroxy-4-cholesten-3-one
Until one of the discontinuation criteria is met
Measured: Up to 18 months
Expansion part: Overall response
Antitumor activity evaluated based on RECIST version 1.1, until one of the discontinuation criteria is met. Antitumor response is rated on a 4-level scale shown below (complete response [CR], partial response [PR], progressive disease [PD] and stable disease [SD]).
Measured: Up to 18 months
Expansion part: Maximum Shrinkage in Target Lesion
Best percent change from baseline in the sum of diameters of all target lesions.
Measured: Up to 18 months
Expansion part: Progression free survival (PFS)
Time from the start of the study treatment until death from any cause or Progressive Disease assessed according to RECIST 1.1.
Measured: Up to 18 months
Expansion part: Time to progression (TTP)
Time from the start of the study treatment until Progressive Disease assessed according to RECIST 1.1.
Measured: Up to 18 months
Expansion part: Time to treatment failure (TTF)
Time from the start of the study drug treatment until discontinuation of study drug treatment for any reason.
Measured: Up to 18 months
Expansion part: Overall survival (OS)
Time from randomization to death from any cause.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study start5 Nov 2013
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Global Development, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038673
- Sponsor's protocol ID
- 5878-CL-0101
- Status last verified
- Oct 2024
- First submitted
- 15 Jan 2014
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Study of Oral ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02038673
- Acronym / sponsor ID
- 5878-CL-0101
- Conditions
- Solid Tumors
- Keywords
- ASP5878, FGFR 1,2,3 and 4 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Global Development, Inc.
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 16 Jan 2014 (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 objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors.
Detailed description
This study consists of two parts. In the dose-escalation part, ASP5878 (orally available novel small-molecule FGFR 1,2,3 and 4 inhibitor, multiple dosing once-a-day (q.d.), multiple dosing twice-a-day (b.i.d.) or 5-day on/2-day off dosing twice-a-day (5on-2off)) is administered to participants with solid tumors in an increasing dose manner, and the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ASP5878 are evaluated in these participants. Cycle 0 consists of 3 days and Cycle 1 and subsequent cycles consist of 28 days each in the dose-escalation part. In the expansion part, 16mg twice-a-day 5-day on/2-day off dose of ASP5878 (5on-2off) is administered to participants with solid tumors and safety, PK, PD and efficacy of ASP5878 are evaluated. The expansion part starts from Cycle 1 and each cycle consists of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Dose escalation part 0.5 mg QD | Experimental | Drug: ASP5878Oral |
| Dose escalation part 1.0 mg QD | Experimental | Drug: ASP5878Oral |
| Dose escalation part 2.0 mg QD | Experimental | Drug: ASP5878Oral |
| Dose escalation part 2.0 mg BID | Experimental | Drug: ASP5878Oral |
| Dose escalation part 4.0 mg BID | Experimental | Drug: ASP5878Oral |
| Dose escalation part 6.0 mg BID | Experimental | Drug: ASP5878Oral |
| Dose escalation part 10.0 mg BID | Experimental | Drug: ASP5878Oral |
| Dose escalation part 20.0 mg BID | Experimental | Drug: ASP5878Oral |
| Dose escalation part 16.0 mg BID | Experimental | Drug: ASP5878Oral |
| Expansion part Urothelial Carcinoma | Experimental | Drug: ASP5878Oral |
| Expansion part Hepatocellular Carcinoma | Experimental | Drug: ASP5878Oral |
| Expansion part Squamous Cell Lung Carcinoma | Experimental | Drug: ASP5878Oral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed solid tumor.
- Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator:
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Predicted life expectancy ≥ 12 weeks in the judgment of the investigator or sub-investigator.
Key exclusion criteria (6 listed)
- Participant with ≥ Grade 2 (CTCAE v 4.0-JCOG) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia).
- Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing).
- A major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study.
- Participant who were treated with other investigational drug or medical device within 4 weeks prior to the planned first day of study drug dosing.
- Participant who has a history of organ transplantation.
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 |
|---|---|---|
| ASP5878oral | Drug | Dose escalation part 0.5 mg QD, Dose escalation part 1.0 mg QD, Dose escalation part 10.0 mg BID, Dose escalation part 16.0 mg BID, Dose escalation part 2.0 mg BID, Dose escalation part 2.0 mg QD, Dose escalation part 20.0 mg BID, Dose escalation part 4.0 mg BID, Dose escalation part 6.0 mg BID, Expansion part Hepatocellular Carcinoma, Expansion part Squamous Cell Lung Carcinoma, Expansion part Urothelial Carcinoma |
Primary outcome
Dose-escalation part and Expansion part: Safety assessed by Adverse Events (AEs)
Time frame: Up to 18 months
Until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part:Safety assessed by Vital signs
Time frame: Up to 18 months
Blood pressure, pulse rate and body temperature, Until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part:Safety assessed by Body weight
Time frame: Up to 18 months
Until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part:Safety assessed by Laboratory tests
Time frame: Up to 18 months
Hematology, blood biochemistry, blood coagulation tests and urinalysis, until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part:Safety assessed by 12-lead ECGs
Time frame: Up to 18 months
ECG: Electrocardiogram, until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part: Ophthalmology
Time frame: Up to 18 months
Eyesight, funduscopy, slit lamp microscopy, and Optical Coherence Tomography, until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part: Bone density measurement
Time frame: Up to 18 months
Until one of the discontinuation criteria is met.
Dose-escalation part and Expansion part: Computed tomography (CT) Imaging assessment
Time frame: Up to 18 months
Until one of the discontinuation criteria is met.
Expansion part only: Echocardiogram
Time frame: Up to 18 months
Until one of the discontinuation criteria is met.
33 secondary outcomes
Dose-escalation part: Pharmacokinetics (PK) parameter of ASP5878 in plasma: Cmax
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part:PK parameter of ASP5878 in plasma: tmax
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part:PK parameter of ASP5878 in plasma: AUClast
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: AUCinf
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: t1/2
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: CL/F
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in plasma: Vz/F
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in urine: Ae
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PK parameter of ASP5878 in urine: CLR
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: Pharmacodynamic (PD) parameter: Serum FGF23 concentrations
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum inorganic phosphorus concentrations
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum calcium concentrations
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum iPTH concentrations
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Dose-escalation part: PD parameter: Serum calcitriol concentrations
Time frame: Day 1 at Cycle 0 and Day 5 (5on-2off) or 27 (q.d./b.i.d.) at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: Cmax
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: tmax
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: AUClast
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: AUCinf
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: t1/2
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: CL/F
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PK parameter of ASP5878 in plasma: Vz/F
Time frame: Day 1 and 5 at Cycle 1
Expansion part: PD parameter: Serum FGF19 concentrations
Time frame: Up to 18 months
Expansion part: PD parameter: Serum FGF23 concentrations
Time frame: Up to 18 months
Expansion part: PD parameter: Serum inorganic phosphorus concentrations
Time frame: Up to 18 months
Expansion part: PD parameter: Serum iPTH concentrations
Time frame: Up to 18 months
Expansion part: PD parameter: Serum calcitriol concentrations
Time frame: Up to 18 months
Expansion part: PD parameter: Serum 7α-hydroxy-4-cholesten-3-one
Time frame: Up to 18 months
Expansion part: Overall response
Time frame: Up to 18 months
Expansion part: Maximum Shrinkage in Target Lesion
Time frame: Up to 18 months
Expansion part: Progression free survival (PFS)
Time frame: Up to 18 months
Expansion part: Time to progression (TTP)
Time frame: Up to 18 months
Expansion part: Time to treatment failure (TTF)
Time frame: Up to 18 months
Expansion part: Overall survival (OS)
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP5878 in people with Solid Tumors, run by Astellas Pharma Inc at 35 sites in 4 countries.
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 6 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Japan, United States, South Korea, Taiwan. 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?
Dose-escalation part and Expansion part: Safety assessed by Adverse Events (AEs) (time frame: Up to 18 months). The study lists 9 primary outcomes in all. 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 31 Oct 2024.