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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 June 2018
Main ID:  NCT02895360
Date of registration: 05/09/2016
Prospective Registration: Yes
Primary sponsor: Basilea Pharmaceutica
Public title: Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Scientific title: An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Date of first enrolment: August 2016
Target sample size: 70
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02895360
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
Switzerland
Contacts
Name:     Thomas Kaindl, MD
Address: 
Telephone: +41 61 567 1505
Email: thomas.kaindl@basilea.com
Affiliation: 
Name:     Thomas Kaindl, MD
Address: 
Telephone:
Email:
Affiliation:  Basilea Pharmaceutica
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age = 18 years

2. Phase 1: Patients with either histologically or cytologically confirmed advanced or
recurrent solid tumor, who failed standard therapy or for whom no effective standard
therapy is available.

Phase 2a: Patients with platinum-resistant/refractory ovarian, fallopian tube or
primary peritoneal cancer (high-grade serous, endometrioid, or carcinosarcoma
histotypes) or glioblastoma in first relapse.

3. Patients with solid tumors must have measurable disease according to Response
Evaluation Criteria in Solid Tumors [RECIST] v1.1.

Patients with recurrent glioblastoma must have measurable disease defined by
contrast-enhancing magnetic resonance imaging.

4. Life expectancy = 12 weeks

5. Acceptable organ and marrow function at baseline (protocol defined laboratory
parameters)

6. Patients with solid tumors must have an Eastern Cooperative Oncology Group (ECOG)
performance status = 1 and patients with recurrent glioblastoma must have an ECOG
performance status = 2.

7. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Patients with solid tumors 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.

Patients with recurrent glioblastoma who have: received radiotherapy within 12 weeks,
unless there is a new area of enhancement consistent with recurrent tumor outside the
radiation field, or there is histological confirmation of unequivocal tumor
progression; received administration of prior antitumor chemotherapy within 4 weeks,
or within 6 weeks for nitrosoureas; undergone surgical resection within 4 weeks or a
stereotactic biopsy/core biopsy within 1 week prior to starting study drug, or have
been treated previously with bevacizumab.

2. Patients who have had prior exposure to BAL101553.

3. Peripheral neuropathy = CTCAE grade 2.

4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or
limit compliance with study requirements

5. Systolic blood pressure (SBP) = 140 mmHg or diastolic blood pressure (DBP) = 90 mmHg
at the screening visit.

6. Blood pressure (BP) combination treatment with more than two antihypertensive
medications.

7. Women who are pregnant or breast-feeding. Men or women of reproductive potential who
are not willing to apply effective birth control.

8. Other protocol-defined exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Neoplasms
Intervention(s)
Drug: BAL101553
Drug: BAL101553 at MTD
Primary Outcome(s)
Maximum tolerated dose (MTD) of BAL101553 based on the number of participants with adverse effects as measure of tolerability at various dose levels [Time Frame: 28 day cycles]
Secondary Outcome(s)
Anti-tumor activity of BAL101553 [Time Frame: 28 day cycles]
AUC of BAL101553 and BAL27862 [Time Frame: 28 day cycles]
Bioavailability of daily oral BAL101553 [Time Frame: One week during Cycle 2]
Cmax of BAL101553 and BAL27862 [Time Frame: 28 day cycles]
Safety and tolerability of BAL101553 treatment based on the number of participants with adverse events at various dose levels [Time Frame: 28 day cycles]
Safety and tolerability of BAL101553 treatment based on the number of participants with ECG changes versus baseline [Time Frame: 28 day cycles]
Safety and tolerability of BAL101553 treatment based on the number of participants with safety laboratory changes versus baseline [Time Frame: 28 day cycles]
Tmax of BAL101553 and BAL27862 [Time Frame: 28 day cycles]
Secondary ID(s)
CDI-CS-003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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