A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer

NCT ID: NCT01335269

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-12-31

Brief Summary

The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.

Secondary objectives are

• determination of the pharmacokinetic (PK) profile;
• exploratory pharmacodynamic analysis; and
• collection of preliminary data on anti-tumour efficacy.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

BI 853520 once daily in a dose escalation schedule

Group Type: EXPERIMENTAL

BI 853520

Intervention Type: DRUG

BI 853520 once daily in a dose escalation schedule

Interventions

BI 853520

BI 853520 once daily in a dose escalation schedule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging

2. Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options

3. Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy).

4. Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2)

5. Age = 18 years

6. Life expectancy = 3 months

7. Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03)

8. Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1

9. Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1, R09-0262)

10. deleted

11. Patients must be willing to provide paired tumour biopsies for PD determination. Refer to section 5.6.3

12. Patients should fit into one of the categories described below:

I. Metastatic adenocarcinoma of the pancreas Patients should have preferably received at least one line of systemic treatment for metastatic disease and preferably not more than 2 prior regimens for metastatic disease.

II. Platinum-resistant ovarian carcinoma, defined as recurrence within 6 months after completion of prior platinum-based chemotherapy Patients should have received preferably no more than 5 previous lines of systemic treatment for metastatic disease.

III. Oesophageal carcinoma Patients with oesophageal carcinoma of adenocarcinoma- or squamous cell histology who have received preferably not more than 2 previous lines of systemic treatment for metastatic disease.

IV. Soft tissue sarcoma Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease.

Exclusion Criteria

• Serious concomitant non-oncological disease/illness
• Active/symptomatic brain metastases
• Second malignancy
• Pregnancy or breastfeeding
• Women or men who are sexually active and unwilling to use a medically acceptable method of contraception.
• Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1300.2.1002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1300.2.1001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1300.2.31003 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

1300.2.31001 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

1300.2.31002 Boehringer Ingelheim Investigational Site

Utrecht, , Netherlands

Countries

Canada; Netherlands

References

Fard D, Giraudo E, Tamagnone L. Mind the (guidance) signals! Translational relevance of semaphorins, plexins, and neuropilins in pancreatic cancer. Trends Mol Med. 2023 Oct;29(10):817-829. doi: 10.1016/j.molmed.2023.07.009. Epub 2023 Aug 17.

Reference Type: DERIVED

PMID: 37598000 (View on PubMed)

de Jonge MJA, Steeghs N, Lolkema MP, Hotte SJ, Hirte HW, van der Biessen DAJ, Abdul Razak AR, De Vos FYFL, Verheijen RB, Schnell D, Pronk LC, Jansen M, Siu LL. Phase I Study of BI 853520, an Inhibitor of Focal Adhesion Kinase, in Patients with Advanced or Metastatic Nonhematologic Malignancies. Target Oncol. 2019 Feb;14(1):43-55. doi: 10.1007/s11523-018-00617-1.

Reference Type: DERIVED

PMID: 30756308 (View on PubMed)

Verheijen RB, van der Biessen DAJ, Hotte SJ, Siu LL, Spreafico A, de Jonge MJA, Pronk LC, De Vos FYFL, Schnell D, Hirte HW, Steeghs N, Lolkema MP. Randomized, Open-Label, Crossover Studies Evaluating the Effect of Food and Liquid Formulation on the Pharmacokinetics of the Novel Focal Adhesion Kinase (FAK) Inhibitor BI 853520. Target Oncol. 2019 Feb;14(1):67-74. doi: 10.1007/s11523-018-00618-0.

Reference Type: DERIVED

PMID: 30742245 (View on PubMed)

Other Identifiers

2010-024609-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1300.2

Identifier Type: -

Identifier Source: org_study_id