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Trial record 1 of 1 for:    DMUC4064A
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A Study Evaluating the Safety and Pharmacokinetics of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02146313
First Posted: May 23, 2014
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This is a Phase I, multicenter, open-label, dose-escalation study of DMUC4064A administered by intravenous (IV) infusion every three weeks (q3w) to cancer participants. The study will employ a traditional 3 + 3 dose escalation design to determine the maximum tolerated dose (MTD) of DMUC4064A against platinum-resistant ovarian cancer. Once a q3w recommended phase II dose (RP2D) is identified, two expansion cohorts (one in platinum-resistant ovarian cancer and another in unresectable pancreatic cancer) may be evaluated to further characterize the safety and activity in these populations.

Condition Intervention Phase
Pancreatic Neoplasms Ovarian Neoplasms Drug: DMUC4064A Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of DMUC4064A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 21 of Cycle 1 (Cycle length[CL]= 21 days) ]
  • Maximum Tolerated Dose of DMUC4064A [ Time Frame: Day 1 up to Day 21 of Cycle 1 (CL=21 days) ]
  • Recommended Part II Dose of DMUC4064A [ Time Frame: Baseline up to safety-follow up (approximately 3.5 years) ]
  • Percentage of Participants with Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to safety-follow up (approximately 3.5 years) ]

Secondary Outcome Measures:
  • Percentage of Participants with Anti-DMUC4064A Antibodies [ Time Frame: Pre-dose (0 hour[H];post infusion (infusion=90 minutes for C1; 30 minutes for C2 and beyond) on Day 1 of Cycle (C) 1-4; at study completion or early termination (approximately 3.5 years (CL=21 days) ]
  • Pharmacokinetic (PK) Profile of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer [ Time Frame: Days 1,2,4,8,11,15 of C1;Days 8,15 of C2-4; at study completion or early termination (approximately 3.5 years) ]
  • Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days) ]
  • Duration of Objective Response [ Time Frame: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days) ]
  • Progression-free Survival (PFS) as Assessed by RECIST v1.1 [ Time Frame: Day 1 of C1 until disease progression or death within 30 days of the last study drug administration, whichever occurs first (approximately 3.5 years) (CL=21 days) ]

Estimated Enrollment: 100
Actual Study Start Date: June 22, 2014
Estimated Study Completion Date: December 30, 2017
Estimated Primary Completion Date: December 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-escalation Cohort
DMUC4064A will be administered to participants at a starting dose of 1.0 milligram per kilogram (mg/kg) by IV infusion q3w and would be monitored for DLTs for 21 days after first infusion of Cycle 1 (cycle length=21 days).
Drug: DMUC4064A
Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days).
Experimental: Platinum-resistant Ovarian Cancer Dose-expansion Cohort
Platinum-resistant Ovarian Cancer participants will be administered with the identified RP2D during the Dose-escalation of DMUC4064A q3w IV for up to until disease progression or death, whichever occurs first.
Drug: DMUC4064A
Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days).
Experimental: Unresectable Pancreatic Cancer Dose-expansion Cohort
Unresectable pancreatic cancer participants will be administered with the identified RP2D during the dose-escalation of DMUC4064A q3w IV for up to until disease progression or death, whichever occurs first.
Drug: DMUC4064A
Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Measurable disease is defined as at least one bi-dimensionally measurable non-lymph node lesion >/=1 centimeter (cm) on long access diameter on computed tomography (CT) or magnetic resonance imaging (MRI) scan or at least one bi-dimensionally measureable lymph node measuring >/=1.5 cm on short access diameter on CT or MRI scan
  • Adequate hemotologic, kidney and liver function
  • Highly effective contraception as defined by the protocol Participants with Ovarian Cancer
  • Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Documentation of mucin 16 (MUC16) expression by either serum carcinoma antigen 125 (CA125) >=2 x ULN or by immunohistochemistry [IHC] by central review
  • Disease that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen
  • Progression or relapse from prior platinum-based chemotherapy must be documented radiographically by RECISTv1.1 criteria

For ovarian cancer dose expansion cohorts only:

  • Not more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer

Participants with Pancreatic Cancer:

  • Histologic documentation of incurable, locally advanced, or metastatic pancreatic ductal adenocarcinoma consisting of unresectable pancreatic ductal adenocarcinoma (i.e., participants who are not considered eligible for surgical resection with curative intent), including recurrence of previously resected disease
  • Documented MUC16 expression from archival or fresh tissue by IHC central review
  • Participants for whom no further standard of care therapy exists, must have received standard of care chemotherapy in the adjuvant or advanced/metastatic setting
  • No more than two prior chemotherapy regimens administered for the treatment of pancreatic cancer in the adjuvant or advanced/metastatic setting

Exclusion Criteria:

  • Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to Day 1
  • Prior treatment with MUC16 targeted therapy (e.g., oregovomab [OvaRex] or abagovomab) including DMUC5754A
  • Prior treatment with an monomethyl auristatin E (MMAE)-containing antibody-drug conjugate (ADC)
  • Palliative radiation to bone metastases within 2 weeks prior to Day 1
  • Prior radiation to lung fields
  • Major surgical procedure within 4 weeks prior to Day 1
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (including human immunodeficiency virus [HIV] and atypical mycobacterial disease but excluding fungal infections of the nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
  • Evidence of significant uncontrolled concomitant diseases, such as ocular toxicities, diabetes, cardiovascular disease; nervous system, renal, hepatic, endocrine, or gastrointestinal disorders; autoimmune disease, or a serious non-healing wound or fracture
  • Clinically significant pulmonary symptoms and signs, any active pulmonary or respiratory infection at enrollment, pulmonary infiltrates on screening CT scan of the chest that are associated with symptoms (including dyspnea), resting or exercise arterial oxygen saturation (SpO2) <90%, requirement for supplementary oxygen at rest or exercise (either continuously or intermittently), moderate (40%-60% predicted) or severe (<40% predicted) decreased diffusing capacity for carbon monoxide (DLCO) or mild (>60% </= lower limit of normal [LLN]% predicted) decrease with clinically significant symptoms
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, adequately controlled limited basal cell skin cancer, or synchronous primary endometrial cancer or prior primary endometrial cancer if protocol criteria are met
  • Untreated or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases may be eligible
  • Current Grade >1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Pregnancy or breastfeeding
  • Inability to comply with study and follow-up procedures
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participants at high risk from treatment complications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146313


Locations
United States, Florida
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States, 34232
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
United States, New Jersey
Hackensack Univ Med Ctr
Hackensack, New Jersey, United States, 07601
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02146313     History of Changes
Other Study ID Numbers: GO29213
First Submitted: May 21, 2014
First Posted: May 23, 2014
Last Update Posted: August 25, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders