Phase 1 Study of KHK2898 in Subjects With Advanced Solid Tumors

NCT01516645 | Terminated Phase 1

• 1 other identifier: KHK2898-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.

Conditions

Solid Tumour

Keywords

Squamous cell type tumor

Outcome Measures

Primary Outcomes (1)

• Adverse Event collection and assessment

  Adverse Event collection and assessment will be done for all 54 potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).

  at least 28 days or up to 24 weeks

Secondary Outcomes (2)

• Evaluate preliminary evidence of efficacy

  eight weeks

• Profile of Pharmacokinetics

  Pre-dose, 1, 2, 4, 6-8, 24, 48, 72, 96, 168, 240-288, 336 hours post-dose

Study Arms (1)

KHK2898

EXPERIMENTAL

Drug: KHK2898

Interventions

KHK2898 DRUG

injection

KHK2898

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has a histopathological-documented, measurable or non-measurable, locally advanced unresectable primary or metastatic solid tumor unresponsive to standard therapy or for which there is no standard therapy available.
• The subject has PD during or following the last treatment regimen as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1 guidelines)11.
• The subject has a life expectancy \>3 months.
• The subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 at study entry.
• The subject is ≥ 18 years of age.
• The subject has a pre-study echocardiogram or multigated acquisition scan with left ventricular ejection fraction ≥ 50%.
• The subject has recovered to Grade ≤ 1 by the CTCAE v 4.0313, from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for cancer, with the exception of alopecia or peripheral neuropathy (the latter of which must have resolved to Grade ≤ 2).
• The subject has preserved organ function as defined below. All parameters must be evaluated within 7 days prior to the first dose of KHK2898.
• a) Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ×Upper limits of normal (ULN), or ≤ 5.0 × ULN in subjects with metastatic liver disease
• b) Hemoglobin ≥ 9 g/dl (without transfusion in the preceding 7 days)
• c) Total bilirubin ≤ 1.5 × ULN
• d) Creatinine ≤ 1.5 × ULN
• e) ANC ≥ 1.5 × 109/L (unsupported by growth factors in the preceding 21 days)
• f) Platelets ≥ 100 × 109/L (without transfusion or growth factor in the preceding 7 days)
• The subject has provided signed informed consent. Written informed consent must be obtained prior to performing any study-related procedures. For subject \< 21 years old who is not married, written informed consent must be taken from the subject and his/her parents/ legal guardians.

You may not qualify if:

• The subject has received anti-cancer chemotherapy, hormonal therapy (other than LH-RH agonists/pure antagonists for prostate cancer, which are allowed to be continued if the subject has already been on one for at least 2 months at the time of enrollment), radiotherapy, immunotherapy, or investigational agents within 4 weeks (6 weeks for mitomycin C and nitrosoureas) prior to the first dose of KHK2898.
• The subject has received monoclonal antibodies within 4 weeks of the first dose of KHK2898.
• The subject had major surgery within 4 weeks prior to the first dose of KHK2898.
• The subject has known symptomatic brain metastases (screening/baseline MRI of the brain is only required when there is clinical suspicion of central nervous system (CNS) involvement or past history of treated brain metastasis). Subjects with treated brain metastasis (radiotherapy and/or surgery) will be eligible if:
• a) They have completed treatment for their brain metastasis \> 4 weeks prior to scheduled study treatment start date;
• b) They are neurologically stable;
• c) They are not receiving corticosteroids or corticosteroids in doses no greater than physiological replacement (e.g., dexamethasone \< 1.5 mg/day); and
• d) They have a screening/baseline MRI scan of the brain that specifically verifies no evidence of CNS hemorrhage and no active gadolinium enhancing lesions; and
• e) Subjects with primary brain/CNS malignancy (e.g., gliomas, lymphomas) are excluded.
• The subject has leptomeningeal disease.
• The subject is pregnant (confirmed by beta human chorionic gonadotrophin \[β-HCG\]) or is lactating.
• The subject has a significant uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics, clinically significant cardiac disease \[class II, III, or IV of the New York Heart Association classification (NYHA)\],14 unstable angina pectoris, myocardial infarction within 6 months or is post angioplasty or stenting within 6 months, uncontrolled hypertension (i.e., systolic blood pressure (BP) \> 150 mm Hg, diastolic BP \> 90 mm Hg), found on two consecutive measurements separated by a 1-week period, clinically significant cardiac arrhythmia, or uncontrolled diabetes.
• The subject has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
• The subject has known active hepatitis B or C or other active (non-malignant) liver disease.
• The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety, ability to provide consent, or limit his/her compliance with study requirements.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Singapore, Singapore

Location

Study Design

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

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

SG (1)