NCT00710710 is a Phase 2 clinical trial of BI 2536 in Pancreatic Neoplasms, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT00710710?

NCT00710710 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT00710710?

Interventions in NCT00710710: BI 2536.

What condition does NCT00710710 study?

NCT00710710 studies Pancreatic Neoplasms.

Is NCT00710710 still recruiting?

NCT00710710 is currently completed. Last updated 4 May 2022.

Are results published for NCT00710710?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-05-04 · How we verify

NCT00710710

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer

Completed Phase 2 Results posted Last updated 4 May 2022

What this trial tests

Phase 2 trial testing BI 2536 in Pancreatic Neoplasms in 89 participants. Completed in 14 October 2008.

Timeline

1 August 2006

Primary endpoint
14 October 2008

14 October 2008

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	1 August 2006
Primary completion	14 October 2008
Estimated completion	14 October 2008
Sites	10 locations across Austria, Germany

Drugs / interventions tested

BI 2536

Conditions studied

Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Pancreatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Best Objective Response Evaluated According to the RECIST Criteria by Independent Review Primary · Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

Best objective response: Tumour assessment by independent review of tumour imaging by an external contract research organization (CRO) according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the bas

Confirmed best overall response

Group	Value	95% CI
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0
200mg BI 2536 IV on Day 1	1
60mg BI 2536 IV on Day 1-3	1
200mg BI 2536 IV on Day 1	11
60mg BI 2536 IV on Day 1-3	10
200mg BI 2536 IV on Day 1	22
60mg BI 2536 IV on Day 1-3	25

Unconfirmed best overall response

Group	Value	95% CI
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0
200mg BI 2536 IV on Day 1	1
60mg BI 2536 IV on Day 1-3	2
200mg BI 2536 IV on Day 1	20
60mg BI 2536 IV on Day 1-3	18
200mg BI 2536 IV on Day 1	13
60mg BI 2536 IV on Day 1-3	16

Tumour Control After the Fourth Treatment Course Secondary · Tumour measurements performed at screening (day -21 to -1) and at the end of of the fourth 3-week treatment cycle, up to 105 days.

Tumour control rate was defined as the number of patients in a treatment arm who had completed 4 courses of treatment and presented with Stable Disease (SD), Partial Response (PR), or Complete Remission (CR). Tumour assessment by independent review of tumour imaging according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target le

Group	Value	95% CI
200mg BI 2536 IV on Day 1	7
60mg BI 2536 IV on Day 1-3	4
200mg BI 2536 IV on Day 1	14
60mg BI 2536 IV on Day 1-3	19
200mg BI 2536 IV on Day 1	22
60mg BI 2536 IV on Day 1-3	20

Duration of Overall Response Secondary · Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

The duration of overall response was measured from the time measurement criteria were met for complete remission (CR) or partial remission (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented, taking as reference for progressive disease the smallest measurements recorded since the treatment started. Tumour assessment by independent review of tumour imaging by an external CRO according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit.

Group	Value	95% CI
200mg BI 2536 IV on Day 1	42	± NA
60mg BI 2536 IV on Day 1-3	141	± 138.59

Progression Free Survival (PFS) Secondary · Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

Progression free survival (PFS) was defined as the duration of time from randomisation to time of progression or death. For patients without documented progression at the time of analysis, PFS was censored as the total observation time without new anti-cancer therapy. PFS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. Progressive disease: At least a 20% increase in the sum of Longest Diameter (LD) of target l

Group	Value	95% CI
200mg BI 2536 IV on Day 1	47	43 – 87
60mg BI 2536 IV on Day 1-3	46	43 – 56

Overall Survival (OS) Secondary · From first treatment till the end of the trial or when a patient concluded the trial, up to 336 days.

Overall survival (OS) was the time from first treatment until death. If there was no occurrence of death or progression until the last follow-up of the trial, the time was to be censored at the date of last trial visit. OS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. The secondary endpoint "One-year survival" was integrated into the secondary endpoint overall survival.

Group	Value	95% CI
200mg BI 2536 IV on Day 1	154	103 – 302
60mg BI 2536 IV on Day 1-3	148	81 – 315

Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment Secondary · Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

Best objective response: Tumour assessment by investigator assessment of tumour imaging according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable diseas

Confirmed best overall response

Group	Value	95% CI
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0
200mg BI 2536 IV on Day 1	11
60mg BI 2536 IV on Day 1-3	11
200mg BI 2536 IV on Day 1	28
60mg BI 2536 IV on Day 1-3	32

Unconfirmed best overall response

Group	Value	95% CI
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0
200mg BI 2536 IV on Day 1	36
60mg BI 2536 IV on Day 1-3	38
200mg BI 2536 IV on Day 1	3
60mg BI 2536 IV on Day 1-3	5

One-year Survival Secondary · 1 year, see description for detailed definition of the time frame.

One-year survival was defined as survival at 1 year after randomisation. For the cohort of first line patients, this time point coincided with the beginning of treatment with the Trial drug. For second line patients, 1 year survival was defined as 1 year after the start of the previous first line treatment for pancreatic cancer.

Group	Value	95% CI
200mg BI 2536 IV on Day 1	4
60mg BI 2536 IV on Day 1-3	5

Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response Secondary · Blood samples for CA19-9 analysis were collected on Days 1, 2, and 5 of each treatment period, up to 357 days.

Number of participants with carbohydrate antigen 19-9 (CA19-9) response rate was defined as the proportion of patients with a decrease in CA19-9 serum levels of ≥25% from baseline in 2 consecutive measurements performed ≥4 weeks apart. Additionally, the proportion of patients with an improved response was assessed, i.e. a decrease in CA19-9 of ≥75% at 2 consecutive measurements ≥4 weeks apart. By definition, a positive CA19-9 response could not occur in patients with normal baseline CA19-9 levels.

CA19-9 response

Group	Value	95% CI
200mg BI 2536 IV on Day 1	41
60mg BI 2536 IV on Day 1-3	41
200mg BI 2536 IV on Day 1	2
60mg BI 2536 IV on Day 1-3	2

Improved CA19-9 response

Group	Value	95% CI
200mg BI 2536 IV on Day 1	43
60mg BI 2536 IV on Day 1-3	43
200mg BI 2536 IV on Day 1	0
60mg BI 2536 IV on Day 1-3	0

Number of Participants With Dose Limiting Toxicity (DLT) Secondary · Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

Dose limiting toxicity (DLT) was defined as drug-related CTCAE (Common Terminology Criteria for Adverse Events, version 3.0) grade ≥3 non-haematological toxicity (excluding untreated nausea, vomiting or diarrhoea), drug related CTCAE grade 4 neutropenia for ≥7 days and / or complicated by infection of CTCAE grade 4, or drug related CTCAE grade 4 haematological toxicity other than neutropenia.

Group	Value	95% CI
200mg BI 2536 IV on Day 1	32
60mg BI 2536 IV on Day 1-3	27
200mg BI 2536 IV on Day 1	11
60mg BI 2536 IV on Day 1-3	15

Quality of Life Assessment, Including Clinical Benefit Response: Overall Health Secondary · Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days.

Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent).

Group	Value	95% CI
200mg BI 2536 IV on Day 1	3.8	± 1.17
60mg BI 2536 IV on Day 1-3	4.1	± 1.41

Quality of Life Assessment, Including Clinical Benefit Response: Quality of Life Secondary · Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days.

Group	Value	95% CI
200mg BI 2536 IV on Day 1	3.8	± 1.29
60mg BI 2536 IV on Day 1-3	4.2	± 1.45

Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Secondary · From first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.

Number of participants with incidence and intensity of Adverse Events (AE) graded according to CTCAE. Intensity of AEs was scaled according to US-NCI CTCAE, version 3.0. Severity grades 1 to 5 were based on the following general guidelines, with unique clinical descriptions of severity for each AE: * Grade 1 Mild * Grade 2 Moderate * Grade 3 Severe * Grade 4 Life-threatening or disabling * Grade 5 Death

Group	Value	95% CI
200mg BI 2536 IV on Day 1	5
60mg BI 2536 IV on Day 1-3	5
200mg BI 2536 IV on Day 1	7
60mg BI 2536 IV on Day 1-3	4
200mg BI 2536 IV on Day 1	12
60mg BI 2536 IV on Day 1-3	16
200mg BI 2536 IV on Day 1	9
60mg BI 2536 IV on Day 1-3	9

Adverse events — posted to ClinicalTrials.gov

Time frame: from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200mg BI 2536 IV on Day 1

Serious: 22/43 (51%)

Deaths: 32/43

60mg BI 2536 IV on Day 1-3

Serious: 23/43 (53%)

Deaths: 35/43

Serious adverse events (67 terms)

Reaction	System	200mg BI 2536 IV on Day 1	60mg BI 2536 IV on Day 1-3
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Subileus	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Infection	Infections and infestations	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Cholestasis	Hepatobiliary disorders	—	—
Somnolence	Nervous system disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Thrombosis	Vascular disorders	—	—
Anal fissure	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Duodenal obstruction	Gastrointestinal disorders	—	—

Other adverse events (45 terms — click to expand)

Reaction	System	200mg BI 2536 IV on Day 1	60mg BI 2536 IV on Day 1-3
Fatigue	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Haemoglobin decreased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Pyrexia	General disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Pain	General disorders	—	—
Weight decreased	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Insomnia	Psychiatric disorders	—	—
Hypertension	Vascular disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Drug administration error	Injury, poisoning and procedural complications	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Polyneuropathy	Nervous system disorders	—	—
Sleep disorder	Psychiatric disorders	—	—

Most-reported serious reactions: Malignant neoplasm progression, Abdominal pain, Pneumonia, Febrile neutropenia, Leukopenia, Subileus, Pyrexia, Infection.

Data from ClinicalTrials.gov NCT00710710 adverse events section.

Sponsor's own description

The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The two sides of chromosomal instability: drivers and brakes in cancer.
Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
Epigenetic treatment of pancreatic cancer: is there a therapeutic perspective on the horizon?
Hessmann E, Johnsen SA, Siveke JT, Ellenrieder V. · · 2017 · cited 100× · PMID 27811314 · DOI 10.1136/gutjnl-2016-312539
Development of synthetic lethality in cancer: molecular and cellular classification.
Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6
Targeting Plk1 Sensitizes Pancreatic Cancer to Immune Checkpoint Therapy.
Zhang Z, Cheng L, Li J, Qiao Q, et al · · 2022 · cited 63× · PMID 35950917 · DOI 10.1158/0008-5472.can-22-0018
Evolving Therapeutic Strategies to Exploit Chromosome Instability in Cancer.
Thompson LL, Jeusset LM, Lepage CC, McManus KJ. · · 2017 · cited 55× · PMID 29104272 · DOI 10.3390/cancers9110151
Dual-target inhibitors of bromodomain and extra-terminal proteins in cancer: A review from medicinal chemistry perspectives.
Feng L, Wang G, Chen Y, Chen Y, et al · · 2022 · cited 43× · PMID 34633088 · DOI 10.1002/med.21859
Second-Generation Antimitotics in Cancer Clinical Trials.
Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
An updated patent review of BRD4 degraders.
Ma Z, Zhang C, Bolinger AA, Zhou J. · · 2024 · cited 17× · PMID 39219068 · DOI 10.1080/13543776.2024.2400166

Verify or expand the search:

Other trials of BI 2536

Trials testing the same drug.

NCT00412880 — BI 2536 Second Line Monotherapy in SCLC · Phase 2 · completed
NCT00376623 — Efficacy and Safety of BI 2536 in Advanced or Metastatic Non Small Cell Lung Cancer · Phase 2 · completed

Other recruiting trials for Pancreatic Neoplasms

Currently open trials in the same condition.

NCT07504471 — Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhib · Phase 2 · recruiting
NCT07139236 — Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD · recruiting
NCT06885697 — Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Includi · Phase 1 · recruiting
NCT06939023 — Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3) · NA · recruiting
NCT06953193 — Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia · NA · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00710710 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 4 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00710710.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing