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A Two Part, Phase 1, Multicenter, Open-label Study of DKN-01 Given Intravenously. Part A: A Dose-Escalation Study in Patients With Multiple Myeloma or Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)


Phase 1
30 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Solid Tumors, Non-Small Cell Lung Cancer

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Trial Information

A Two Part, Phase 1, Multicenter, Open-label Study of DKN-01 Given Intravenously. Part A: A Dose-Escalation Study in Patients With Multiple Myeloma or Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)


Part A of this trial consists of 4 treatment arms of DKN-01. It is a dose escalation study
in patients with multiple myeloma or advanced solid tumors. Patients must be refractory or
intolerant to all standard/approved therapy(ies). At each dose level, 3 subjects will be
treated. If none of the 3 subjects develop a dose limiting toxicity after a minimum of 4
weeks of treatment, subsequent dose escalation will proceed according to the same schedule.
Part B consists of dose confirmation in patients with NSCLC. Patients must be refractory or
intolerant to all standard/approved therapy(ies). Approximately 15 patients may be enrolled
in Part B.


Inclusion Criteria:



- Part A Only: Patients with histological or cytological confirmed multiple myeloma or
advanced solid tumors. For multiple myeloma, patients must have symptomatic myeloma
as defined by the International Myeloma Working Group inclusive of measurable serum
and/or urine monoclonal protein (M-protein) or for those patients without elevations
they must have measurable increased concentrations of free light chains

- Part B Only: Patients with previously treated, histologically confirmed advanced
NSCLC with progressive disease requiring therapy

- Parts A and B as follows:

- Patients must be refractory or intolerant to all standard/approved therapy(ies)

- Patients with solid tumors must have one or more metastatic tumors measurable on
computed tomography (CT) scan using Response Evaluation Criteria in Solid Tumors
(RECIST) criteria

- Radiation for symptomatic lesions outside the central nervous system (CNS) must have
been completed at least 2 week prior to study enrollment

- Treated brain metastases will be allowed, provided they are asymptomatic. Patients
must be off corticosteroids for at least 2 week prior to study entry

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1

- Life expectancy of at least 3 months

- Ambulatory patients greater than or equal to (≥) 30 years of age

- Signed, Institutional Review Board (IRB) - approved informed consent

- Females with child bearing potential must have had a negative serum pregnancy test
within 7 days of study entry

- Acceptable liver function:

- Bilirubin less than or equal to (≤) 1.5 times upper limit of normal Aspartate
transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine
transaminase (ALT) serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl
transferase (GGT) and alkaline phosphatase ≤ 2.5 times upper limit of normal (if
liver metastases are present, then ≤ 5 times the upper limit of normal (ULN) is
allowed)

- Acceptable renal function:

- Solid tumor patients: Calculated creatinine clearance greater than or equal to
(≥) 60 milliliters/per minute (mL/min) using the Cockcroft and Gault Method

- Multiple myeloma patients: Serum creatinine ≤ 1.5 x ULN and/or a calculated
creatinine clearance ≥ 45 mL/min using the Cockcroft and Gault Method

- Acceptable hematologic status:

- Granulocyte ≥ 1500 cells/cubic millimeter (cells/mm3)

- Hemoglobin ≥ 9 grams per deciliter (g/dL)

- Platelet counts:

- Solid tumor patients ≥ 100,000 (plt/mm3)

- Multiple myeloma patients ≥ 75,000 (plt/mm3)

- Urinalysis:

- No clinically significant abnormalities

- Acceptable coagulation status:

- Prothrombin Time/Partial Thromboplastin Time (PT/PTT) ≤ 1.2 x ULN (unless
receiving anticoagulation therapy whereby eligibility will be based upon INR as
follows)

- International Normalization Ratio (INR) ≤ 1.6 (unless receiving anticoagulant
therapy)

- If receiving warfarin; INR ≤ 3.0 and no active bleeding (that is, no
bleeding within 14 days prior to first dose of study therapy)

- For men and women of child-producing potential, the use of effective contraceptive
methods during the study and for women 18 months following the last dose of study
drug

- NOTE: Women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control) during the study,
and women must agree to use adequate contraception prior to study entry and for
18 months after their last dose of study drug. Should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures

- Serum calcium:

- For solid tumors only: within institutional normal limits

- Multiple myeloma: ≤ 11.5 milligrams per deciliter (mg/dL)

Exclusion Criteria:

- History of osteonecrosis of the hip or have evidence of structural bone abnormalities
in the proximal femur on magnetic resonance imaging (MRI) scan that are considered
clinically significant or may have an impact on the interpretation of the scan.
Degenerative changes of the hip joint are not exclusionary

- Are unable to tolerate the confinement/noise of an MRI scanner or have any
contraindication for MRI, including but not limited to the following:

- Cardiac pacemakers

- Prosthetic heart valves

- Metallic splinters in the eye

- Ferromagnetic hemostatic clips in the central nervous system or body hemostatic
clips

- Cochlear implants

- Adhesive transdermal patch, if not removed before scans

- New York Heart Association Class 3 or 4, cardiac disease, myocardial infarction
within the past 6 months, unstable arrhythmia, or evidence of ischemia on
echocardiogram (ECG)

- Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 millisecond (msec)
(female) or > 450 (male), or history of congenital long QT syndrome. Any ECG
abnormality that in the opinion of the investigator would preclude safe participation
in the study

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy

- Pregnant or nursing women

- Treatment with radiation therapy, surgery, or chemotherapy, within 1 month prior to
study entry (6 week for nitrosoureas or Mitomycin C)

- Previously treated with an anti-DKK-1 therapy

- Significant allergy to a biological pharmaceutical therapy that, in the opinion of
the investigator, poses an increased risk to the patient

- History of major organ transplant (for example: heart, lungs, liver and kidney)

- Have had an autologous or allogenic bone marrow transplant

- Have current acute leukemia

- Patients diagnosed with colon, prostate, breast or small cell lung cancer

- Have osteoblastic lesions

- Have concomitant disease known to influence calcium metabolism including
hyperparathyroidism, hyperthyroidism and/or Paget's disease of bone

- Unwillingness or inability to comply with procedures required in this protocol

- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

- Serious nonmalignant disease (for example: hydronephrosis, liver failure, or other
conditions) that could compromise protocol objectives in the opinion of the
investigator and/or the sponsor

- Patients who are currently receiving any other investigational agent or have received
an investigational agent within last 30 days or 5 half-lives, whichever is longer

- Patients who are currently receiving lithium chloride (LiCl)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with clinically significant effects

Outcome Description:

For both Parts A and B

Outcome Time Frame:

Baseline to study completion (approximately 3 months)

Safety Issue:

Yes

Principal Investigator

Email: Dekkun@Choruspharma.com

Investigator Role:

Study Director

Investigator Affiliation:

Dekkun Corporation

Authority:

United States: Food and Drug Administration

Study ID:

P100

NCT ID:

NCT01457417

Start Date:

October 2011

Completion Date:

April 2014

Related Keywords:

  • Multiple Myeloma
  • Solid Tumors
  • Non-Small Cell Lung Cancer
  • Cancer
  • Oncology
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasms

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Tyler Cancer CenterTyler, Texas  75702
Northwest Cancer SpecialistsVancouver, Washington  98664
New York Oncology Hematology, P.C.Albany, New York  12208
University of Texas Southwestern Medical CenterDallas, Texas  
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258
Virginia Commonwealth University - Massey Cancer CenterRichmond, Virginia  23298-0037
Institute for Translational Oncology ResearchGreenville, South Carolina  29605
Texas Oncology - Baylor, Charles A. Sammons CenterDallas, Texas  75246