Non-Small Cell Lung Cancer, Ovarian CancerPhase 1NCT01363947
Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
A Phase 1 study testing DNIB0600A in people with Non-Small Cell Lung Cancer, Ovarian Cancer, run by Genentech, Inc. at 7 sites in 2 countries.
Trial summary
Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Ovarian Cancer
- What is being tested?
- DNIB0600A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 14 Jun 2011to 3 Jun 2016
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologic documentation of incurable, locally advanced or metastatic disease that has failed prior chemotherapy and for which no standard therapy exists, including the following: non-squamous NSCLC or non-mucinous and platinum-resistant ovarian cancer
- Availability and willingness to provide an adequate archival sample of tumor
- Measurable disease
- For fertile men or women of childbearing potential, documented willingness to use a highly effective means of contraception
Who cannot join
- Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to study treatment
- Major surgical procedure within 4 weeks prior to study treatment
- Known active bacterial, viral, fungal, mycobacterial, or other infection (including human immunodeficiency virus [HIV] and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Untreated or active central nervous system (CNS) metastases
- Requirement for supplemental oxygen to carry out activities of daily living
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- 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 participant at high risk from treatment complications
- Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
- For participants in the second NSCLC cohort expansion, not more than two prior regimens in the metastatic setting
- Pregnancy or breast-feeding
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Univ of Texas SW Medical Ctr
Dallas, Texas, 75390
Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, 85258
Spain3 sites
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007
About this study
Official title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Patients With Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer
Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
- Being tested
- DNIB0600A
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNIB0600ADrug
Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort (DNIB0600A) | Experimental | Participants will receive IV infusions of DNIB0600A at doses ranging from 0.2 milligrams/kilogram (mg/kg) to 2.8 mg/kg q3w until dose-limiting toxicity (DLT) is reached, or up to 28 cycles. Receives: Drug: DNIB0600A |
| Expansion Cohort (DNIB0600A) | Experimental | Participants will receive 2.4 mg/kg, by IV infusion, of DNIB0600A q3w for up to 26 cycles. Receives: Drug: DNIB0600A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of causality.
Measured: Up to approximately 2 years
Secondary outcomes (4)
Cmax of DNIB0600A for Antibody-Conjugated Monomethyl Auristatin E (acMMAE), Total Antibody, and Unconjugated Monomethyl Auristatin E (MMAE)
Cmax is the peak concentration of a substance in blood serum.
Measured: Day 21
Percentage of Participants with Antibody Formation to DNIB0600A
Serum samples will be analyzed to assess the prevalence of anti-drug antibodies (ADAs) at baseline and the incidence of post-baseline ADAs in each treatment group.
Measured: Up to approximately 84 weeks
Percentage of Participants with Objective Response (OR)
OR is defined as a complete or partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum on study. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.
Measured: Up to approximately 84 weeks
Duration of Objective Response (DOR)
OR is defined as a complete or partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum on study. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.
Measured: Up to approximately 84 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study start14 Jun 2011
- Primary completion3 Jun 2016
- Study completion3 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer, Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Maslyar, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363947
- Sponsor's protocol ID
- DNB4987g
- Other IDs
- GO27767, 2014-000527-25, 2014
- Status last verified
- Jun 2017
- First submitted
- 26 May 2011
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Patients With Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01363947
- Acronym / sponsor ID
- DNB4987g
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2011 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 3 Jun 2016 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort (DNIB0600A) | Experimental | Drug: DNIB0600AParticipants will receive IV infusions of DNIB0600A at doses ranging from 0.2 milligrams/kilogram (mg/kg) to 2.8 mg/kg q3w until dose-limiting toxicity (DLT) is reached, or up to 28 cycles. |
| Expansion Cohort (DNIB0600A) | Experimental | Drug: DNIB0600AParticipants will receive 2.4 mg/kg, by IV infusion, of DNIB0600A q3w for up to 26 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologic documentation of incurable, locally advanced or metastatic disease that has failed prior chemotherapy and for which no standard therapy exists, including the following: non-squamous NSCLC or non-mucinous and platinum-resistant ovarian cancer
- Availability and willingness to provide an adequate archival sample of tumor
- Measurable disease
- For fertile men or women of childbearing potential, documented willingness to use a highly effective means of contraception
Key exclusion criteria (10 listed)
- Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to study treatment
- Major surgical procedure within 4 weeks prior to study treatment
- Known active bacterial, viral, fungal, mycobacterial, or other infection (including human immunodeficiency virus [HIV] and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Untreated or active central nervous system (CNS) metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNIB0600ASeveral dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression. | Drug | Dose Escalation Cohort (DNIB0600A), Expansion Cohort (DNIB0600A) |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years
An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of causality.
4 secondary outcomes
Cmax of DNIB0600A for Antibody-Conjugated Monomethyl Auristatin E (acMMAE), Total Antibody, and Unconjugated Monomethyl Auristatin E (MMAE)
Time frame: Day 21
Percentage of Participants with Antibody Formation to DNIB0600A
Time frame: Up to approximately 84 weeks
Percentage of Participants with Objective Response (OR)
Time frame: Up to approximately 84 weeks
Duration of Objective Response (DOR)
Time frame: Up to approximately 84 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Maslyar, M.D. study director
Genentech, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNIB0600A in people with Non-Small Cell Lung Cancer, Ovarian Cancer, run by Genentech, Inc. at 7 sites in 2 countries.
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 5 inclusion and 10 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 7 Jun 2017. 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, Spain. 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 Adverse Events (AEs) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2017.