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Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

StatusActive, Not Recruiting
PhasePhase 1/2
Started2015-07-14
View on ClinicalTrials.gov ↗

Amendment history

2026-03-17
Study Identification, Study Status, Study Design, Eligibility v46
Completion date2025-12→2027-12
Start date2015-07→2015-07-14
Enrollment target230→253
Eligibility criteria+80 characters
[...] edure is performed. Men and women 18 years of age or older. SubjectsParticipants with histologically or cytologically confirmed advanced sol [...] se 2 are detailed in the protocol. a. For Phase 2 Cohort 3, subjectsparticipants must have histologically confirmed PTCL (local pathology re [...] naplastic large-cell lymphoma. For Phase 2 Cohorts 3 and 4, patientsparticipants must have evidence of documented progressive disease and must have received at least two prior systemic therapies. SubjectsParticipants with CD30-positive lymphoma must have received, be ineligib [...] that brentuximab vedotin is locally approved [...]
2025-01-05
Study Status v45
Re-verified, no change to tracked fields
2024-12-03
Study Status v44
Primary completion dateestimated 2024-10→confirmed 2022-10
Completion date2024-10→2025-12
2024-08-30
Study Status v43
Re-verified, no change to tracked fields
2024-07-09
Study Identification, Study Status, Sponsor/Collaborators v42
Lead sponsorAstex Pharmaceuticals, Inc.→Taiho Oncology, Inc.
Show 41 earlier versions
2024-06-25
5 amendments v37-v41
5 re-verifications since 2023-08-31, no change to tracked fields
2023-08-03
Study Status v36
Primary completion date2023-05→2024-10
Completion date2023-05→2024-10
2023-02-16
Study Status, Contacts/Locations v35
Study sites69→68
2022-11-18
2 amendments v33-v34
2 re-verifications since 2022-10-05, no change to tracked fields
2022-08-09
Study Status v32
Primary completion date2022-05→2023-05
Completion date2022-05→2023-05
2022-01-24
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v31
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2021-10→2022-05
Study sites70→69
2021-03-29
Study Status, Contacts/Locations v30
Study sites68→70
2021-02-23
Study Status, Contacts/Locations v29
Study sites62→68
2021-01-05
Study Status, Contacts/Locations v28
Study sites60→62
2020-12-13
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v27
Primary completion date2021-06→2021-10
Completion date2021-10→2022-05
Enrollment target320→230
Eligibility criteria+906 characters
[...] elected for study in Phase 2 are detailed in the protocol. a) . For Phase 2 Cohort 3, subjects must have histologically conf [...] ved, be ineligible for, or intolerant to brentuximab vedotin, provided that brentuximab vedotin is locally approved and available. Subjects with mycosis fungoides or Sezary syndrome must have received, be ineligible or intolerant to mogamulizumab, provided that mogamulizumab is locally approved and available. In the Phase 2 portion of the protocol only, subjects must [...] to response criteria appropriate for their type of cancer. a) . For Phase 2 Cohort 3 (PTCL), measurable dis [...] [...]
Secondary endpointsdetails revised at 4 of 11 entries
Study description+12 characters
[...] vity in nonclinical models. The Phase 1 portion of the study (completed) will determine the MTD, RP2D, and recommended dosing regime [...]
2020-11-06
Study Status, Contacts/Locations v26
Study sites57→60
2020-10-27
Study Status, Contacts/Locations v25
Study sitesdetails revised at 2 of 57 sites
2020-10-08
Study Status, Contacts/Locations v24
Study sitesdetails revised at 1 of 57 sites
2020-10-07
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 57 sites
2020-10-02
Study Status, Contacts/Locations v22
Study sites57 entries, revised
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
2020-09-29
Study Status, Contacts/Locations v21
Study sites56→57
2020-09-25
Study Status, Contacts/Locations v20
Study sites49→56
2020-08-14
Study Status, Contacts/Locations v19
Study sites47→49
2020-06-18
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v18
Trial statusActive, Not Recruiting→Recruiting
Study sites46→47
2020-04-16
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Study sites46 entries, revised
HenryBritish FordColumbia HealthCancer SystemsAgency
2019-12-12
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v16
Enrollment target230→320
Eligibility criteria+435 characters
[...] ave received, be ineligible or intolerant to mogamulizumab. 5) In the Phase 2 portion of the protocol only, subjects must h [...] to response criteria appropriate for their type of cancer. 6a) For Phase 2 Cohort 3 (PTCL), measurable disease by contrast-enhanced diagnostic CT (at least 1 nodal lesion ≥1.5 cm or extranodal lesions >1.0 cm) is required. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Acceptable organ function, as evidenced by the following lab [...] >=50 mL/min. Amylase and lipase <=ULN [Applies to Phase 2]. 8. Women of child-bearing potential (according to reco [...] [...]
Secondary endpoints9 to 11 entries
Efficacy - radiographic evaluationDuration of tumorantitumor sizeresponse Progression-free usingsurvival Overall RECIST 1.1 criteria or another appropriate method if disease is not measureable using RECIST criteriasurvival
Study description-776 characters
[...] and tumor growth inhibitory activity in nonclinical models. ASTX660 has not been previously evaluated in human subjects. The Phase 1 portion of the study will determine the MTD, RP2 [...] lated toxicity, or until the study is closed by the sponsor. Tolerability and safety of study treatment will be evaluated throughout the study by collection of clinical and laboratory data. In Phase 2, antitumor response will be assessed using computed tomography (CT) or magnetic resonance imaging (MRI) scans or other appropriate disease evaluation methods. [...]
2019-08-20
Study Status, Eligibility, Contacts/Locations v15
Study sites29→46
Eligibility criteria+1,228 characters
[...] selected for study in Phase 2 are detailed in the protocol. a) For Phase 2 Cohort 3, subjects must have histologically confirmed PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study: adult T-cell lymphoma/leukemia, extranodal natural killer (NK)/T-cell lymphoma nasa [...] In the Phase 2 portion of the protocol only, subjects must h [...] ng to response criteria appropriate for their type of cancer (as explained in Section 9.1). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Accept [...] [...]
2019-05-09
Study Status, Contacts/Locations v14
Study sites30→29
2019-01-11
Study Status, Contacts/Locations v13
Primary completion date2019-07→2021-06
Completion date2019-12→2021-10
Study sites29→30
2018-11-09
Study Status, Contacts/Locations v12
Study sites28→29
2018-07-06
Study Status, Contacts/Locations v11
Study sites15→28
2018-05-18
Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility v10
Primary completion date2018-07→2019-07
Completion date2018-12→2019-12
Enrollment target200→230
Eligibility criteria+901 characters
[...] ol only, subjects must have measurable disease according to RECISTresponse v1criteria appropriate for their type of cancer (as explained in Section 9.1, or evaluable disease that can be reliably and consistently followed). Eastern Cooperative Oncology Group (ECOG) performance stat [...] epted formula) or measure creatinine clearance >=50 mL/min. Amylase and lipase <=ULN [Applies to Phase 2]. Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]; see protocol for details) must not be pregnant or breastfeeding and must have a negat [...] ncy test at scr [...]
Secondary endpoints3 to 9 entries
PKPharmacokinetic profile - derived from measurementoutcome of studyconcentration-time drugcurve (AUC) Pharmacokinetic outcome of maximum concentration in(Cmax) Pharmacokinetic serialoutcome plasmaof minimum concentration (Cmin) Pharmacokinetic outcome of time to maximum concentration (Tmax) Pharmacokinetic outcome of samples over time Pharmacokinetic outcome of samples over time Pharmacokinetic outcome of analysis of ASTX660 metabolites if applicable
Primary endpoints2 to 3 entries
Efficacy (Phase 2) - radiographicantitumor evaluationactivity ofassessed tumor size using RECIST 1.1 criteria or another appropriate method ifby disease iscontrol notrate measureable(DCR) Efficacy using(Phase RECIST2) criteria- antitumor activity assessed by objective response rate (ORR)
Study description+288 characters
[...] ratory data. In Phase 2, antitumor response will be assessed according to standard Response Evaluation Criteria in Solid Tumors (RECIST v1.1) using computed tomography (CT) or magnetic resonance imaging (MRI) scans or assessedother using another reliable method ofappropriate disease evaluation appropriatemethods. In forsubjects with solid tumors, response will be evaluated according to standard Response Evaluation Criteria in Solid Tumors (RECIST v1.1; Appendix 3). In subjects with DLBCL and PTCL, antitumor response will be evaluated according to the tumor2014 typeLugano classification (Append [...] [...]
2018-03-22
Study Status, Contacts/Locations v9
Study sites13→15
2018-01-12
Study Status, Contacts/Locations v8
Study sites7→13
2017-11-02
Study Status, Conditions, Arms and Interventions, Contacts/Locations v7
Study sites4→7
2017-08-22
Study Status, Arms and Interventions, Eligibility v6
Study arms8→9
Eligibility criteria+3,965 characters
Inclusion Criteria: Able to understand and comply with the protocol and study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed. Men and women 18 years of age or older. Subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma that is metastatic or unresectable, and for whom standard life-prolonging measures are not available. Specific tumor types that will be selected for study in Phase 2 are detailed in the protocol. In the Phase 2 portion of the protocol only, subjects [...] [...]
2017-03-13
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v5
Enrollment target86→200
Study arms1→8
Eligibility criteria+225 characters
[...] r whom standard life-prolonging measures are not available. In the Phase 2 portion of the protocol only, subjects must have measurable disease according to RECIST v1.1, or evaluable disease that can be reliably and consistently followed. Eastern Cooperative Oncology Group (performance status): 0 to 2 Acceptable organ function Exclusion Criteria: Hypersensitivity to ASTX660, excipients [...]
Secondary endpoints2 to 3 entries
Assessment of target (cIAP1) engagement
Primary endpoints2 entries, revised
Efficacy (Phase 2) - radiographic evaluation of tumor size using RECIST 1.1 cr [...] d if disease is not measureable using RECIST criteria Safety (Phase 1) - number of subjects with AEs, DLTs, abnormal clinical laboratory values or physical exam results
Study description+107 characters
[...] ut the study by collection of clinical and laboratory data. AntitumorIn Phase 2, antitumor response will be assessed according to standard Response Ev [...] ed tomography (CT) or magnetic resonance imaging (MRI) scans or assessed using another reliable method of disease evaluation appropriate for the tumor type.
2016-11-08
Study Status, Contacts/Locations v4
Study sites4 entries, revised
city:Pinnacle Scottsdale,Oncology Cedars-Sinai country:Medical UnitedCenter Simlow States,Cancer geoPoint:Hospital {'lat':at 33.50921, 'lon':Yale Start -111.89903}, state: Arizona, status: RECRUITING, zip: 852558 city: Los Angeles, country: United States, geoPoint: {'lat': 34.05223, 'lon': -118.24368}, state: California, status: RECRUITING, zip: 90048 city: New Haven, country: United States, geoPoint: {'lat': 41.30815, 'lon': -72.92816}, state: Connecticut, sta [...] Ids
2016-07-12
Study Status, Contacts/Locations v3
Re-verified, no change to tracked fields
2015-10-22
Study Status, Contacts/Locations v2
Study sites4 entries, revised
city: Los Angeles, country: United States, geoPoint: {'lat': 34.05223, 'lon': -118.24368}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 90048 city: New Haven, country: United States, geoPoi [...] ': 41.30815, 'lon': -72.92816}, state: Connecticut, status: ACTIVE_NOT_RECRUITINGRECRUITING, zip: 06510
2015-09-14
Study Status, Contacts/Locations v1
Study sites4 entries, revised
city: New Haven, country: United States, geoPoint: {'lat': 41.30815, 'lon': -72.92816}, state: Connecticut, status: NOT_YET_RECRUITINGACTIVE_NOT_RECRUITING, zip: 06510 city: San Antonio, country: United States, geoP [...] {'lat': 29.42412, 'lon': -98.49363}, state: Texas, status: NOT_YET_RECRUITINGRECRUITING, zip: 78229
2015-07-17
Original filing
This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.
Trial Details
NCT Number NCT02503423
Lead Sponsor Taiho Oncology, Inc.
Conditions Solid Tumors, Lymphoma
Enrollment 253 participants
Start Date 2015-07-14
Primary Completion 2022-10 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-20