Solid Organ TumorsPhase 1/2NCT01397929

An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors

A Phase 1/2 study testing BAL101553 in people with Solid Organ Tumors, run by Basilea Pharmaceutica at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Organ Tumors
What is being tested?: BAL101553
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 3 sitesUnited Kingdom
Study dates: Jun 2011to Apr 2016
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available:colorectal; gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer; ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative breast
Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125)
Life expectancy ≥ 12 weeks
Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Other protocol-defined inclusion criteria may apply.

Who cannot join

Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies
Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
Peripheral neuropathy ≥ CTCAE v4 grade 2
Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control
Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed as part of the screening examination.
Patients treated with a calcium channel blocker or who require combination of more than 2 antihypertensives to control blood pressure.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

University College London NHS Foundation Trust
London, WC1E 2PG
Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.

Conditions: Solid Organ Tumors
Being tested: BAL101553

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAL101553Drug
Intravenous administration

Study groups in NCT01397929
Study group	Role	What they receive
Drug: BAL101553 at MTD	Experimental	Not described Receives: Drug: BAL101553
Drug: BAL101553 at 50% of MTD	Experimental	Not described Receives: Drug: BAL101553

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553
First-cycle dose limiting toxicities (DLT)
Measured: 28 day cycles

Secondary outcomes (4)

To evaluate safety and tolerability of BAL101553 treatment
Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments
Measured: 28 day cycles
To evaluate BAL101553 pharmacokinetics
BAL101553 and BAL27862 PK parameters including (but not limited to): Cmax (maximum observed plasma concentration), AUC (area under the concentration time curve), half-life, volume of distribution
Measured: 28 day cycles
To assess anti-tumor activity of BAL101553
Response rate per RECIST guidelines
Measured: 28 day cycles
To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553
Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers
Measured: 28 day cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Apr 2016

First posted20 Jul 2011 (estimated)
Study startJun 2011
Primary completionJan 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Organ 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01397929
Sponsor's protocol ID: CDI-CS-001
Status last verified: May 2023
First submitted: 12 Jul 2011
Last updated: 10 May 2023
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Solid Organ Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01397929
Acronym / sponsor ID: CDI-CS-001
Conditions: Solid Organ Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Basilea PharmaceuticaIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jan 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 20 Jul 2011 (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.

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drug: BAL101553 at MTD	Experimental	Drug: BAL101553
Drug: BAL101553 at 50% of MTD	Experimental	Drug: BAL101553

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age ≥ 18 years
Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available:colorectal; gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer; ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative breast
Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125)
Life expectancy ≥ 12 weeks
Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)

Key exclusion criteria (8 listed)

Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies
Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
Peripheral neuropathy ≥ CTCAE v4 grade 2
Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control

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
BAL101553Intravenous administration	Drug	Drug: BAL101553 at 50% of MTD, Drug: BAL101553 at MTD

Primary outcome

To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553
Time frame: 28 day cycles
First-cycle dose limiting toxicities (DLT)

4 secondary outcomes

To evaluate safety and tolerability of BAL101553 treatment
Time frame: 28 day cycles
To evaluate BAL101553 pharmacokinetics
Time frame: 28 day cycles
To assess anti-tumor activity of BAL101553
Time frame: 28 day cycles
To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553
Time frame: 28 day cycles

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 10 May 2023.

Related trials for Solid Organ Tumors

Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
RecruitingPhase 3
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
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Active, not recruitingPhase 1
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Not yet recruiting
Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression
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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.

Marc Engelhardt, MD study director

Basilea Pharmaceutica International Ltd

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BAL101553 in people with Solid Organ Tumors, run by Basilea Pharmaceutica at 3 sites in United Kingdom.

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 8 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553 (time frame: 28 day cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01397929.

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 10 May 2023.