Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT02895360
• Date of registration: 05/09/2016
• Prospective Registration: No
• 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 24, 2016
• Target sample size: 43
• Recruitment status: Completed
• 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
• 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 [Time Frame: 28 day cycle]

Secondary Outcome(s)

AUC of BAL101553 and BAL27862 [Time Frame: 0 to 168 hours post-dose at Day 1 of Cycle 1 and Cycle 2 in each cohort in Phase 1, 28-day cycles]

Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria [Time Frame: 28 day cycles]

Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1 [Time Frame: Relative oral bioavailability, calculated as dose-normalized AUC0-t following oral administration on Cycle 2 Day 21 divided by dose normalized AUC0-8 following IV administration on Cycle 1 Day 1 for each cohort.]

Cmax of BAL101553 and BAL27862 [Time Frame: Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.]

Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication [Time Frame: TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose]

Tmax of BAL101553 and BAL27862 [Time Frame: Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.]

Secondary ID(s)

CDI-CS-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/10/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02895360