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Pancreatic NeoplasmsPhase 1NCT02146313

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

A Phase 1 study testing DMUC4064A in people with Pancreatic Neoplasms and Ovarian Neoplasms, run by Genentech, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms, Ovarian Neoplasms
What is being tested?
DMUC4064A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
7 sitesUnited States
Study dates
22 Jun 2014to 18 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 greater than or equal to (>/=) 1 centimeter (cm) on long access diameter on computed tomography (CT) or magnetic resonance imaging (MRI) scan or at least one bi-dimensionally measurable lymph node measuring >/=1.5 cm on short access diameter on CT or MRI scan
  • Adequate hematologic, 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
Show all 16Show fewer
  • Documentation of mucin 16 (MUC16) expression by either serum carcinoma antigen 125 (CA125) >=2 x Upper limit of normal (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

Who cannot join

  • 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 a 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
Show all 17Show fewer
  • 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) less than (<) 90 percent (%), 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 greater than (>) 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Inst.

    Boston, Massachusetts, 02115

  • Hackensack Univ Med Ctr

    Hackensack, New Jersey, 07601

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

    Sarasota, Florida, 34232

Other trials in United States

About this study

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

This is a Phase 1, 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 2 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.

Being tested
DMUC4064A
Medical subject headings
Pancreatic Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DMUC4064ADrug

    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).

Study groups in NCT02146313
Study groupRoleWhat they receive
Dose-escalation CohortExperimentalDMUC4064A 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).
Receives: Drug: DMUC4064A
Platinum-resistant Ovarian Cancer Dose-expansion CohortExperimentalPlatinum-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.
Receives: Drug: DMUC4064A
Unresectable Pancreatic Cancer Dose-expansion CohortExperimentalUnresectable 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.
Receives: Drug: DMUC4064A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: Day 1 up to Day 21 of Cycle 1 (Cycle length[CL]= 21 days)

  2. Maximum Tolerated Dose of DMUC4064A

    Measured: Day 1 up to Day 21 of Cycle 1 (CL=21 days)

  3. Recommended Part II Dose of DMUC4064A

    Measured: Baseline up to safety-follow up (approximately 3.5 years)

  4. Percentage of Participants with Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Measured: Baseline up to safety-follow up (approximately 3.5 years)

Secondary outcomes (5)

  1. Percentage of Participants with Anti-DMUC4064A Antibodies

    Measured: 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)

  2. Pharmacokinetic (PK) Profile of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer

    Measured: 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)

  3. Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days)

  4. Duration of Objective Response

    Measured: At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days)

  5. Progression-free Survival (PFS) as Assessed by RECIST v1.1

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study start22 Jun 2014
  3. Primary completion18 Jun 2018
  4. Study completion18 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146313
Sponsor's protocol ID
GO29213
Status last verified
Jun 2018
First submitted
21 May 2014
Last updated
21 Jun 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DMUC4064A in people with Pancreatic Neoplasms and Ovarian Neoplasms, run by Genentech, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 21 of Cycle 1 (Cycle length[CL]= 21 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.

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