Study · A Multicenter, Randomized, …

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma

completed NCT01514188

Aldoxorubicin (INNO-206, doxorubicin-EMCH) 350 mg/m² IV (260 mg/m² doxorubicin equivalent) vs doxorubicin 75 mg/m² IV, Day 1 every 21 days for up to 6 cycles, first-line

Phase II Soft-tissue sarcoma Sponsor CytRx Corporation (registry sponsor now ImmunityBio, Inc.) FPI 2012-01-11

Study design

Design: Phase 2b, multicenter, international, randomized 2:1 (aldoxorubicin:doxorubicin), open-label, parallel-group; stratified by ECOG PS (0-1 vs 2) and prior chemotherapy; primary endpoint PFS by independent central RECIST 1.1 review open-label
Arms (2): Doxorubicin 75 mg/m2Aldoxorubicin (INNO-206) 350 mg/m2
Primary endpoint: Progression-free survival (registration to documented progression by RECIST 1.1 or death from any cause), independent central review
Enrollment: 126 of 105 target
Data cutoff: 2014-12-15
Provenance: Aldoxorubicin (INNO-206) vs doxorubicin, first-line advanced soft-tissue sarcoma: CytRx Phase 2b INNO-206-P2-STS-01, ClinicalTrials.gov NCT01514188 (completed; results posted 2024-05-29) and Chawla SP et al., JAMA Oncol 2015;1(9):1272-1280 (PMID 26378637). The REGISTRY RECORD AND THE PUBLICATION ARE REAL: title, design, arms, eligibility, outcomes, the 34 registry locations and every aggregate the generator is calibrated to (participant flow, baseline, posted outcome measures, serious and other adverse-event tables, deaths, per-country enrollment, LVEF eTable 4). EVERY PARTICIPANT-LEVEL ROW IS SIMULATED — subjects, dates, adverse events, dosing, labs, vitals, visits, deviations and time-to-event values are synthetic, generated by priv/demo_data/generators/aldox_p2b so that per-arm aggregates reproduce the posted results. Site PI names shown in GalenOps are placeholders, not the real investigators. Parameters: research/aldox_p2b/literature.json, measurements.json, operations.json, outcomes.json, population.json, registry.json, safety.json.

LicenseClinicalTrials.gov public registry data (U.S. National Library of Medicine terms of use; registry records are not copyrighted); published aggregate results cited from Chawla et al. 2015. Simulated participant data: synthetic, demo use inside GalenOps only.

UpstreamClinicalTrials.gov API v2, GET /api/v2/studies/NCT01514188 (results first posted 2024-05-29); Chawla et al. JAMA Oncol 2015 with Supplements 1 (protocol INNO-206-P2-STS-01 Amendment 2) and 2 (eTables 1-4); evidence base research/aldox_p2b/{registry,literature}.json; synopsis priv/demo_data/aldox_p2b_synopsis.md; participant-level data simulated by priv/demo_data/generators/aldox_p2b/build.py

Extracted 2026-09-29

Open source record

Agentic orchestration

Runs all 13 lifecycle agents below in order; each records what it did, the evidence it used, and escalates to a human only on exception.

Horizon 3

Idle — the checklist below shows the last recorded state of every step.

Study lifecycle checklist 7 / 13

13 steps in trial order. Expand a step to see exactly what the agent did, the evidence it computed, and what it produced; steps needing a decision link to the review queue.

Decisions awaiting you 12

Every escalation the agents raised on this study, decided here exactly as on the dashboard. Open an item's details before deciding; a note goes on the audit trail.

deciding as portal.reviewer

high site · confirm_onsite_visit

Site "Royal Perth Hospital (Perth, Australia)" is a statistical outlier among the 34 sites of "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (risk score 0.496; visit-window compliance 50% vs study mean 88%, z=-2.92; missed-visit rate 12% vs study mean 3%, z=2.73). An on-site visit is proposed for 2026-10-13; the other sites stay on remote/centralized monitoring.

Escalated by monitoring_agent claude-sonnet-5 · 10 d ago · took 5.5 s

high site · confirm_onsite_visit

Site "Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)" is a statistical outlier among the 34 sites of "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (risk score 0.34; lab flags per patient 18.00 vs study mean 9.74, z=2.54). An on-site visit is proposed for 2026-10-13; the other sites stay on remote/centralized monitoring.

high study · review_aged_queries

86 data queries are open past the 14-day SLA on "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (86 past 30 days, 16 safety-critical P1). JSCDM benchmark: ≥80% reviewed within 2 weeks, target 95%. Oldest: [AE-006 · 5298 d] AE Anaemia (grade 4) for P2B-001 (onset 2012-03-28) is CTCAE grade 4 but not flagged serious. Confirm seriousn; [AE-006 · 5292 d] AE Neutropenia (grade 4) for P2B-003 (onset 2012-04-03) is CTCAE grade 4 but not flagged serious. Confirm seri; [VS-001 · 5230 d] Visit Cycle 2 Day 1: infusion (V3) for P2B-005 occurred on 2012-06-04, 5 d late against planned day 22 (2012-0; [VS-001 · 5210 d] Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-005 occurred on 2012-06-; [VS-001 · 5208 d] Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-003 occurred on 2012-06

Escalated by cdm_agent claude-sonnet-5 · 10 d ago · took 3.5 s

critical adverse_event · assess_serious_event

OVERDUE SAE — SAE Narrative Subject P2B-132 (46-year-old male), enrolled in the Aldoxorubicin (INNO-206) 350 mg/m2 treatment arm, experienced a serious adverse event of Cholecystitis (System Organ Class: Hepatobiliary disorders), assessed as Grade 3 in severity. The event met the criterion of seriousness due to hospitalization. Onset occurred on 2013-09-29, with resolution on 2013-10-13, for a total duration of 14 days. The outcome was reported as RECOVERED/RESOLVED. The investigator's causality assessment was UNLIKELY (not suspected as related to study treatment). No dose adjustment was made as a result of this event (action taken with study treatment: DOSE NOT CHANGED). This event was classified as unexpected, as it is not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). As an unexpected serious adverse event assessed as not related to study drug, expedited reporting was required within 15 days per ICH E2A guidelines, with a due date of 2013-10-14. This report is OVERDUE. Death within 30 days of the event: No. Additional Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

Escalated by safety_agent claude-sonnet-5 · 10 d ago · took 13.8 s

critical adverse_event · assess_serious_event

OVERDUE SAE — SAE Narrative – Subject P2B-130 Subject P2B-130 is a 51-year-old female enrolled in the study arm Aldoxorubicin (INNO-206) 350 mg/m2. The subject experienced a serious adverse event of Anaemia (Grade 3), System Organ Class: Blood and lymphatic system disorders, classified as serious due to hospitalization. Onset of the event occurred on 2013-10-17, with resolution documented on 2013-11-10, corresponding to a duration of 24 days. The outcome was reported as RECOVERED/RESOLVED. Following the onset of the event, the action taken with study treatment was DRUG INTERRUPTED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected (related to study drug). The event was assessed as unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Per ICH E2A expedited reporting requirements, this event triggered a 15-day reporting clock, with an expedited report due on 2013-11-01. This report is OVERDUE. Death within 30 days of the event: No. Additional source description: Grade 3 Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

critical adverse_event · assess_serious_event

OVERDUE SAE — SAE Narrative Subject P2B-134 is a 66-year-old female enrolled in the study arm Aldoxorubicin (INNO-206) 350 mg/m2. The subject experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, classified as serious due to hospitalization. Onset of the event occurred on 2013-10-22. The event resolved on 2013-11-26, with an event duration of 35 days. The outcome was reported as RECOVERED/RESOLVED. As a result of the event, the following action was taken with study treatment: DOSE REDUCED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected in relation to study treatment. Expectedness assessment: unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Death within 30 days of the event: No. Regulatory reporting: This event met criteria for expedited reporting under a 15-day timeline (ICH E2A). The expedited report was due on 2013-11-06. Based on the information provided, this report is OVERDUE. Additional narrative detail from source Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

critical adverse_event · assess_serious_event

OVERDUE SAE — Serious Adverse Event Narrative Subject P2B-134 is a 66-year-old female enrolled in the study, assigned to the Aldoxorubicin (INNO-206) 350 mg/m2 treatment arm. The subject experienced a serious adverse event of Febrile neutropenia (System Organ Class: Blood and lymphatic system disorders), graded as Grade 4 in severity. The event met seriousness criteria on the basis of hospitalization. Onset of the event occurred on 2013-10-29, with resolution documented on 2013-11-04, for a total event duration of 6 days. The outcome was reported as RECOVERED/RESOLVED. In response to the event, study treatment action taken was DRUG INTERRUPTED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected in relation to study treatment. The event was assessed as unexpected, as it is not listed on the doxorubicin hydrochloride label (used as a doxorubicin class proxy reference). Regulatory reporting: Per the applicable expedited reporting clock (15 days, consistent with ICH E2A for other serious unexpected suspected adverse reactions), the exp Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

critical adverse_event · assess_serious_event

OVERDUE SAE — Serious Adverse Event Narrative Subject P2B-129 is a 64-year-old female enrolled in the study arm receiving Doxorubicin 75 mg/m2. The subject experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, classified as serious due to hospitalization. Onset occurred on 2013-10-30, with cycle 5 onset noted in the source description. The event resolved on 2013-12-02, resulting in an event duration of 33 days. As a result of the event, study treatment action taken was: drug interrupted. The event outcome was recorded as RECOVERED/RESOLVED. The investigator's causality assessment was PROBABLE, and the causality category was classified as suspected (related to study drug). The event was assessed as unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Death within 30 days of the event: No. Regulatory Reporting Status: Per ICH E2A guidelines, this event met criteria for expedited reporting under the 15-day serious unexpected reaction timeline. The expedited report was due on 2013-11-14. This report is Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

high study · review_tmf_gaps

TMF for "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" is 60% complete against the DIA TMF Reference Model v3.2.1 (closeout stage); 10 auditable artifact(s) missing or incomplete — top gaps: 03.01.01 Regulatory Submission, 07.02.01 Expedited Safety Report, 02.03.01 Clinical Study Report. Confirm the filed TMF findings and assign owners.

Escalated by tmf_agent claude-sonnet-5 · 10 d ago · took 4.4 s

Agent reasoning trail 13 runs

Explainable, traceable, inspection-ready — every automated action records why it did what it did and the evidence it used (FDA/EMA January 2026 AI guiding principles).

When	Agent	Outcome	Model · duration	Reasoning
29 Sep 202623:43:19 UTC	tmf_agent H1	escalated Review task #431b4b64	Claude · claude-sonnet-5 4.4 s	This TMF self-audit against the DIA TMF Reference Model v3.2.1 at closeout stage shows completeness of 0.6, below the 0.8 threshold, triggering escalation. Of 18 auditable artifacts, 8 are fully present, 5 partial, and 5…
29 Sep 202623:43:15 UTC	medical_writing_agent H1	escalated Review task #d47f7fcf	Claude · claude-sonnet-5 14.4 s	This draft CSR (per ICH E3) covers 126 randomized subjects: Doxorubicin 75 mg/m2 (n=40) and Aldoxorubicin (INNO-206) 350 mg/m2 (n=86). Overall, 106 completed (84.1%) and 20 discontinued. Adverse events occurred in 111/12…
29 Sep 202623:43:00 UTC	biostats_agent H1	escalated Review task #efd69b84	Claude · claude-sonnet-5 4.5 s	12 TLF outputs were generated per ICH E3 Section 14 for this Phase II soft-tissue sarcoma study (126 randomised, 140 screened). Safety shows a clear differential: any AE 80.0% (Doxorubicin 75 mg/m2) vs 95.2% (Aldoxorubic…
29 Sep 202623:42:56 UTC	supply_agent partner	completed	Claude · claude-sonnet-5 3.7 s	This study is completed, so the report is retrospective rather than a forward forecast. Across the trial, 573 IP kits (Aldoxorubicin (INNO-206) and Doxorubicin) were dispensed to 123 patients, averaging 4.7 kits per pati…
29 Sep 202623:42:52 UTC	termination_watch_agent H2	completed	Claude · claude-sonnet-5 4.3 s	This completed Phase II sarcoma study (INNO-206 vs doxorubicin) accrued 126 of 105 planned (120.0% attainment) between 2012-01-11 and 2013-07-27, finishing 1.5 months ahead of the 18-month plan with last patient in on 20…
29 Sep 202623:42:48 UTC	retention_agent H2	completed	Claude · claude-sonnet-5 4.2 s	This is a retrospective review of a completed study (INNO-206 vs Doxorubicin, soft-tissue sarcoma, Phase II), with 0 active patients and 0 patients scored, so no live dropout risk scoring applies. Among 126 ever-consente…
29 Sep 202623:42:44 UTC	safety_agent H2	escalated Review task #88a0ac27	Claude · claude-sonnet-5 13.8 s	Across 608 coded events in 123 treated patients, 5 new safety reports were triaged: all 5 are serious (grade 3–4), 4 with causality "suspected" and 1 "not_suspected" (Cholecystitis), and all 5 have opened review tasks wi…
29 Sep 202623:42:30 UTC	cdm_agent H1	escalated Review task #273e3923	Claude · claude-sonnet-5 3.5 s	The CDM sweep of this Phase 2b INNO-206 vs doxorubicin sarcoma study (140 subjects) ran 18 edit checks; 2 fired: AE-006 "Grade ≥4 AE not flagged serious" (16 hits, P1) and VS-001 "Visit outside protocol window" (70 hits,…
29 Sep 202623:42:26 UTC	monitoring_agent H2	escalated Review task #a883a6e2	Claude · claude-sonnet-5 5.5 s	Centralized statistical monitoring reviewed 34 sites and 140 patients across 11 KRIs (as of 2014-12-15), following the TransCelerate RBM KRI set and Barnes et al. 2021 RBQM approach. No site reached the composite thresho…
29 Sep 202623:42:21 UTC	recruitment_agent H2	completed	Claude · claude-sonnet-5 4.5 s	This is a completed Phase II sarcoma trial reviewed retrospectively. The funnel shows 140 entered screening, 14 screened-only, 126 accrued, 106 completed, 20 withdrawn, with a screen-fail rate of 10.0% (14/140). Pace rat…
29 Sep 202623:42:16 UTC	site_activation_agent H2	completed	Claude · claude-sonnet-5 4.5 s	This study is complete, with all 34 sites activated and contracts executed. Contract days of 55 sit between the benchmark median of 33 d and Q3 of 77 d (Martinez et al. 2016, Trials 17:106), so none breach the negotiatio…
29 Sep 202623:42:12 UTC	protocol_agent H1	completed	Claude · claude-sonnet-5 3.3 s	The SPIRIT checklist review of protocol v1.0 (approved) checked 60 items, covering 22, with 38 gaps: 2 critical, 13 major, 23 minor. Amendment risk is 1.0 (formula: min(1, 0.04×minor + 0.08×major + 0.15×critical), heuris…
29 Sep 202623:42:09 UTC	feasibility_agent H1	completed	Claude · claude-sonnet-5 4.6 s	This study is assessed as feasible (score 1.0): target enrollment of 105 was already reached, with 126 consented across 34 contracted sites in 7 countries (AUS, HUN, IND, ROU, RUS, UKR, USA). Demand was 0.1716 per site-m…

Protocol versions 1

Every version stays on file. Read any version in full; edit the newest to save the next draft and re-run the protocol agent's SPIRIT lint on it.

v1.0 approved — — 2026-09-29

Sites 34

Every site contracted for this study or with a participant on it — with this study's contract stage and enrollment. Open a site for its full monitoring picture.

Site	Country	Principal investigator	Site status	Contract	Participants	Risk
Blokhin Cancer Research Center (Moscow, Russia)	RUS	Dr. Moreau	activated	executed 2012-05-25	6 enrolled · 7 on site	KRI 0.299
Border Medical Oncology (Wodonga, Australia)	AUS	Dr. Kim	activated	executed 2012-09-14	1 enrolled · 1 on site	KRI 0.0
CTRC Institute for Drug Development, University of Texas (San Antonio, TX)	USA	Dr. Muller	activated	executed 2012-05-14	10 enrolled · 11 on site	KRI 0.312
Christian Medical College (Vellore, India)	IND	Dr. Dubois	activated	executed 2013-03-14	2 enrolled · 2 on site	KRI 0.0
Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania)	ROU	Dr. Silva	activated	executed 2012-07-09	3 enrolled · 4 on site	KRI 0.313
Curie Manavata Cancer Centre (Nashik, India)	IND	Dr. Nolan	activated	executed 2012-11-01	1 enrolled · 1 on site	KRI 0.0
Delhi State Cancer Institute (Mandoli, India)	IND	Dr. Muller	activated	executed 2013-03-31	2 enrolled · 2 on site	KRI 0.0
Delhi State Cancer Institute (Pune, India)	IND	Dr. Okafor	activated	executed	0 enrolled · 0 on site	KRI 0.0
Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia)	AUS	Dr. Dubois	activated	executed 2013-02-02	3 enrolled · 3 on site	KRI 0.391
Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)	IND	Dr. Ito	activated	executed 2012-09-17	3 enrolled · 4 on site	KRI 0.32
Hemato Oncology Clinic, Vedanta Institute of Medical Science (Thaltej, India)	IND	Dr. Moreau	activated	executed	0 enrolled · 0 on site	KRI 0.0
Jehangir Clinical Development Centre Pvt Ltd (Pune, India)	IND	Dr. Tanaka	activated	executed 2012-11-27	1 enrolled · 1 on site	KRI 0.0
Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)	UKR	Dr. Okafor	activated	executed 2013-02-10	3 enrolled · 3 on site	KRI 0.34
M.S. Ramaiah Medical College and Hospitals (Bangalore, India)	IND	Dr. Reyes	activated	executed 2012-09-28	1 enrolled · 1 on site	KRI 0.0
Medisprof SRL (Cluj-Napoca, Romania)	ROU	Dr. Kowalski	activated	executed 2013-03-28	1 enrolled · 1 on site	KRI 0.0
Mount Medical Centre (Perth, Australia)	AUS	Dr. Jansen	activated	executed	0 enrolled · 0 on site	KRI 0.0
Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel (Dnipropetrovsk, Ukraine)	UKR	Dr. Reyes	activated	executed 2012-06-12	2 enrolled · 2 on site	KRI 0.0
Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary" (Chernivtsi, Ukraine)	UKR	Dr. Ito	activated	executed 2013-02-23	1 enrolled · 1 on site	KRI 0.0
Noble Hospital Clinical Research Department 1st Floor (Hadapsar, India)	IND	Dr. Rossi	activated	executed 2012-07-14	1 enrolled · 1 on site	KRI 0.0
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania)	ROU	Dr. Novak	activated	executed 2012-08-15	3 enrolled · 3 on site	KRI 0.383
Pennsylvania Hematology Oncology Associates (Philadelphia, PA)	USA	Dr. Tanaka	activated	executed 2012-08-28	2 enrolled · 2 on site	KRI 0.0
Royal Hobart Hospital (Hobart, Australia)	AUS	Dr. Novak	activated	executed 2013-03-06	3 enrolled · 3 on site	KRI 0.409
Royal North Shore (St Leonards, Australia)	AUS	Dr. Rossi	activated	executed 2012-08-08	2 enrolled · 2 on site	KRI 0.0
Royal Perth Hospital (Perth, Australia)	AUS	Dr. Silva	activated	executed 2012-07-02	2 enrolled · 4 on site	KRI 0.496
Sarcoma Oncology Center (Santa Monica, CA)	USA	Dr. Reyes	activated	executed 2011-12-16	16 enrolled · 16 on site	KRI 0.21
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)	ROU	Dr. Jansen	activated	executed 2012-11-25	2 enrolled · 2 on site	KRI 0.0
Stanford University (Stanford, CA)	USA	Dr. Nolan	activated	executed 2012-05-31	5 enrolled · 5 on site	KRI 0.237
State Health Centre Oncology Department (Budapest, Hungary)	HUN	Dr. Clarke	activated	executed 2012-04-09	26 enrolled · 30 on site	KRI 0.359
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)	RUS	Dr. Clarke	activated	executed 2012-04-26	10 enrolled · 12 on site	KRI 0.248
State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)	UKR	Dr. Nolan	activated	executed 2012-11-23	3 enrolled · 3 on site	KRI 0.401
Tata Memorial Hospital, Department of Medical Oncology (Mumbai, India)	IND	Dr. Kim	activated	executed 2013-03-04	2 enrolled · 2 on site	KRI 0.0
The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia)	AUS	Dr. Kowalski	activated	executed 2012-07-25	4 enrolled · 5 on site	KRI 0.276
University of Iowa (Iowa City, IA)	USA	Dr. Okafor	activated	executed 2012-02-16	4 enrolled · 5 on site	KRI 0.218
Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine)	UKR	Dr. Tanaka	activated	executed 2012-08-16	1 enrolled · 1 on site	KRI 0.0

Feasibility 1

7 countries (AUS, HUN, IND, …) score 1.0 34 sites · 105 patients · 18 mo

Feasible: target of 105 already reached (126 consented). Narrow funnel: 3 restrictive criteria (treatment-naïve / prior-therapy exclusion, ECOG / performance-status limit, organ-function laboratory thresholds) leave a screen-pass fraction of 0.125, so assumed capacity is 0.0375 enrollable patients per site-month. Termination-risk multipliers (Zhang & DuBois 2023): phase II OR 1.58 (product 1.58). ClinicalTrials.gov comparator (soft tissue sarcoma, phase 2, n=1344): 11.7% terminated, 4.3% for accrual, median enrollment 42.

Supply forecasts 0

No forecast yet

Run the supply step to size the first kit order.

Regulatory submissions 0

Nothing submitted yet

The regulatory step compiles the IND/CTA once the protocol is approved.

Study documents 14 files

Everything generated or filed for this study. Open a file to preview it as a PDF.