Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Ovarian Cancer Advanced Solid Malignant Tumors

Outcome Measures

Primary Outcomes (1)

Number (percent) of subjects experiencing adverse events (AEs) after treatment with U3-1565
Number (percent) of subjects experiencing adverse events (AEs) after treatment with U3-1565
6 months

Secondary Outcomes (4)

determine the maximum tolerated dose (MTD) or tolerability of maximum administered dose (MAD).
12 months
Greatest percent reduction in the sum of longest diameters (SLD) of measurable tumors, if applicable, after U3 1565 treatment
24 months
Changes in pharmacodynamic biomarkers in blood and other body fluid specimens
24 months
Changes in tumor perfusion and vascularity after U3-1565 treatment using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI)
24 months

Study Arms (3)

Part 1 Dose Escalation

EXPERIMENTAL

Dose escalation of U3 1565 will follow a modified 3+3 study design with a starting intravenous (IV) dose of 2 mg/kg. A maximum of 2 new subjects will receive their first dose of U3-1565 per 24-hour period during the dose-escalation phase. Subsequent escalating doses of 8, 16, and 24 mg/kg are planned. Three to 6 subjects will be enrolled in 4 sequential dose level cohorts.

Drug: U3-1565

Part 2a Dose Expansion

EXPERIMENTAL

For Part 2a, 6 or 12 subjects with advanced solid malignant tumors will be enrolled and treated at the MTD or MAD to further define the safety and tolerability of U3-1565. These additional subjects are expected to permit the detection of relatively rare toxicities that would not likely be observed during the dose escalation part of the study, whose 3+3 design implies a maximum of 6 subjects only will be treated at the MTD or MAD. Six subjects will be treated; however, if toxicities meeting the definition of DLT are observed during the first cycle of treatment, 6 more subjects will be treated for a total of 12 subjects.

Drug: U3-1565

Interventions

U3-1565Drug

U3 1565 will be provided as a sterile, frozen solution. Each glass vial will contain 1.1 mL (1 mL extractable) of study medication with a concentration of 100 mg/mL. U3 1565 will be diluted in a final volume of 100 mL and administered by continuous IV infusion over 60 minutes. Infusion times can be extended to a maximum of 120 minutes for subjects unable to tolerate the 60 minute infusion.

Part 1 Dose EscalationPart 2a Dose ExpansionPart 2b Dose Expansion and Anti-tumor Impact

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Pathologically documented advanced solid malignant tumor refractory to standard treatment or for which no standard treatment is available.
Evaluable tumor for all parts of the study and, only for enrollment in Part 2b, measurable tumor per RECIST version 1.1. However, subjects with advanced ovarian cancer may be enrolled in Part 2b even if they do not have a tumor measurable per RECIST version 1.1, as long as they have circulating levels of CA125 higher than 35 U/mL.

Sponsors & Collaborators

Daiichi Sankyo
Industrylead

Study Sites (4)

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Univ. Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

MeSH Terms

Interventions

U3-1565

Study Officials

Giorgio Senaldi, MD, PhD
Daiichi Sankyo
STUDY DIRECTOR

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 7, 2011

Study Start

January 2011

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

History of lymphoma, leukemia, or other hematopoietic malignancy.
History of human immunodeficiency virus (HIV) positivity. HIV testing is not required for establishing eligibility.
History of bleeding diathesis.
History of idiosyncratic reactions to antibody drug products.
History of stem cell or bone marrow transplant.
History of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF; New York Heart Association \> Class II), unstable angina or unstable cardiac arrhythmia requiring medication
History of clinically significant pulmonary disease after receiving epidermal growth factor receptor- (EGFR) targeting agents.
Any concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
Clinically active brain metastases defined as symptomatic or requiring treatment with steroids or anti-convulsants.
Unresolved toxicities from prior anti-cancer therapy defined as toxicities, except alopecia, not yet resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade =\< 1 or baseline values. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator or Sponsor (eg, Grade 2 chemotherapy-induced neuropathy).
Mean QTcF (Fridericia's correction) intervals \> 450 msec for male subjects and \> 470 msec for female subjects, based on screening electrocardiogram (ECG).
Moderate to severe cardiac valvular abnormalities identified by echocardiography at screening.
Hematological values, as follows:
Absolute neutrophil count (ANC) \< 1.5 X 109/L Platelet count \< 100 X 109/L Hemoglobin (Hb) \< 9 g/dL - Renal function, as follows: Creatinine \> 1.5 X upper limit of normal (ULN) or creatinine clearance \< 60 mL/min, as calculated using the modified Cockcroft Gault equation.
\- Hepatic function, as follows: Aspartate aminotransferase (AST) \> 3 X ULN (if liver metastases are present, \> 5 X ULN).
+7 more criteria

Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Part 1 Dose Escalation

Part 2a Dose Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Part 2b Dose Expansion and Anti-tumor Impact

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Part 1 Dose Escalation

Part 2a Dose Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Part 2b Dose Expansion and Anti-tumor Impact

You may not qualify if:

Source record

Locations