Ovarian CancerPhase 2NCT01991210
A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC)
A Phase 2 study testing DNIB0600A and PLD in people with Ovarian Cancer, run by Genentech, Inc. at 36 sites in 7 countries.
Trial summary
This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- DNIB0600A and PLD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 6 Feb 2014to 17 Aug 2016
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom PLD is appropriate therapy
- No more than 1 prior cytotoxic chemotherapy regimens for the treatment of PROC and not more than 2 total regimens (defined as any therapy [approved or investigational] with intent to treat the ovarian cancer)
- Adequate hematologic, renal and liver function
- Willing and able to perform a patient-reported outcome (PRO) survey (including the possibility of using an electronic PRO device)
- For women of childbearing potential, agreement to use 1 highly effective form of contraception as defined by protocol through the course of study treatment and for 6 months after the last dose of study treatment
Who cannot join
- Primary platinum-refractory disease defined as disease progression during or within 2 months of a first-line, platinum-containing chemotherapy regimen
- Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1
- Palliative radiation within 2 weeks prior to Day 1
- Prior anthracycline therapy, including prior treatment with PLD (for example, Doxil®, Caelyx®, or Lipodox®) in any setting (for example, in combination with carboplatin or as a single agent)
- Prior treatment with NaPi2b or SCL34A2 targeted therapy
- Major surgical procedure within 4 weeks prior to Day 1
Show all 19Show fewer
- Current Grade greater than (>) 1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause
- Left ventricular ejection fraction defined by multigated acquisition (MUGA)/echocardiogram below the institutional lower limit of normal
- Evidence of significant, uncontrolled, concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease
- Known active infection, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (within 4 weeks prior to Cycle 1, Day 1)
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Presence of positive test results for hepatitis B or hepatitis C as detailed in the protocol
- Known history of HIV seropositive status
- 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
- Untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- Pregnancy or breastfeeding
- Known history of NaPi2b deficiency (for example, congenital alveolar microlithiasis or testicular microlithiasis)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Metabolic dysfunction, physical examination finding, or clinical laboratory find giving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or may render the participant at high risk from treatment complications
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
United States14 sites
Johns Hopkins Uni; Oncology Center
Baltimore, Maryland, 21231
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Inst.
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Hematology & Oncology Associates
Covington, Louisiana, 70433
Sarah Cannon Cancer Center
Germantown, Tennessee, 38138
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of California Irvine Medical Center
Orange, California, 92868
St. Joseph'S Hospital & Medical Center
Phoenix, Arizona, 85013
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Women & Infants Hospital
Providence, Rhode Island, 02905
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, 85258
Florida Cancer Specialists.
St. Petersburg, Florida, 33705
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, 97062
Spain5 sites
Hospital Universitario Vall d'Hebron; Servicio de Neumologia
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050
United Kingdom5 sites
Sarah Cannon Research Institute
London, W1G 6AD
Christie Hospital
Manchester, M20 3BG
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, L63 4JY
The Royal Marsden Hospital
Sutton, SM2 5PT
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
France4 sites
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, 69008
Hôpital Européen Georges Pompidou
Paris, 75908
HOPITAL TENON; Cancerologie Medicale
Paris, 75970
Institut Gustave Roussy
Villejuif, 94805
Canada3 sites
London Regional Cancer Centre
London, Ontario, N6A 4L6
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, H2L 4M1
Princess Margaret Hospital
Toronto, Ontario, M4X 1K9
Poland3 sites
Bialostockie Centrum Onkologi
Bialystok, 15-027
Wojewodzkie Centrum Onkologii
Gdansk, 80-219
Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON
Warsaw, 04-141
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer
This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks.
- Conditions
- Ovarian Cancer
- Being tested
- DNIB0600A, PLD
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNIB0600ADrug
Also called RO5541081
DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks.
PLDDrug
PLD will be administered at a dose of 40 mg/m^2 IV every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DNIB0600A | Experimental | DNIB0600A will be administered on Day 1 of each cycle (1 cycle = 21 days) until significant toxicity, disease progression, or withdrawal from the study (overall up to approximately 2.5 years). Receives: Drug: DNIB0600A |
| PLD | Active comparator | PLD will be administered on Day 1 of each cycle (1 cycle = 28 days) until significant toxicity, disease progression, or withdrawal from the study (overall up to approximately 2.5 years). Receives: Drug: PLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: From baseline up to disease progression or death within 30 days of last study drug administration (overall up to approximately 2.5 years)
Secondary outcomes (10)
Percentage of Participants With Objective Response According to RECIST v1.1
Measured: From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years)
Duration of Objective Response
Measured: From occurrence of a documented objective response until relapse or death from any cause (overall up to approximately 2.5 years)
Overall Survival (OS)
Measured: From baseline up to death from any cause (overall up to approximately 2.5 years)
Percentage of Participants With Adverse Events (AEs)
Measured: From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years)
Area Under the Concentration-time Curve (AUC) of DNIB0600A
Measured: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Maximum Concentration (Cmax) of DNIB0600A
Measured: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Clearance (CL) of DNIB0600A
Measured: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Elimination Half-life (t1/2) of DNIB0600A
Measured: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Volume of Distribution at Steady State (Vss) of DNIB0600A
Measured: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against DNIB0600A
Measured: Pre-DNIB0600A infusion on Day 1 of Cycles 1-4 (1cycle=21 days), at approximately 15-30 days after last infusion administration (overall up to approximately 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start6 Feb 2014
- Primary completion17 Aug 2016
- Study completion17 Aug 2016
Why it stopped: The primary objective of PFS did not meet pre-specified criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991210
- Sponsor's protocol ID
- GO28609
- Other IDs
- 2012-005776-34
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2013
- Last updated
- 21 Aug 2017
- Results posted
- No
Publications
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PubMed 37407274Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, Moore KN, Mackowiak-Matejczyk B, Pikiel J, Ray-Coquard I, Trask P, Lin K, Schuth E, Vaze A, Choi Y, Marsters JC, Maslyar DJ, Lemahieu V, Wang Y, Humke EW, Liu JF. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023.
PubMed 29401246
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01991210
- Acronym / sponsor ID
- GO28609
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary objective of PFS did not meet pre-specified criteria.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 17 Aug 2016 (actual)
- First posted
- 25 Nov 2013 (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.
This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNIB0600A | Experimental | Drug: DNIB0600ADNIB0600A will be administered on Day 1 of each cycle (1 cycle = 21 days) until significant toxicity, disease progression, or withdrawal from the study (overall up to approximately 2.5 years). |
| PLD | Active comparator | Drug: PLDPLD will be administered on Day 1 of each cycle (1 cycle = 28 days) until significant toxicity, disease progression, or withdrawal from the study (overall up to approximately 2.5 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom PLD is appropriate therapy
- No more than 1 prior cytotoxic chemotherapy regimens for the treatment of PROC and not more than 2 total regimens (defined as any therapy [approved or investigational] with intent to treat the ovarian cancer)
- Adequate hematologic, renal and liver function
Key exclusion criteria (19 listed)
- Primary platinum-refractory disease defined as disease progression during or within 2 months of a first-line, platinum-containing chemotherapy regimen
- Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1
- Palliative radiation within 2 weeks prior to Day 1
- Prior anthracycline therapy, including prior treatment with PLD (for example, Doxil®, Caelyx®, or Lipodox®) in any setting (for example, in combination with carboplatin or as a single agent)
- Prior treatment with NaPi2b or SCL34A2 targeted therapy
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 |
|---|---|---|
| DNIB0600AAlso: RO5541081DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks. | Drug | DNIB0600A |
| PLDPLD will be administered at a dose of 40 mg/m^2 IV every 4 weeks. | Drug | PLD |
Primary outcome
Progression-free Survival According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: From baseline up to disease progression or death within 30 days of last study drug administration (overall up to approximately 2.5 years)
10 secondary outcomes
Percentage of Participants With Objective Response According to RECIST v1.1
Time frame: From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years)
Duration of Objective Response
Time frame: From occurrence of a documented objective response until relapse or death from any cause (overall up to approximately 2.5 years)
Overall Survival (OS)
Time frame: From baseline up to death from any cause (overall up to approximately 2.5 years)
Percentage of Participants With Adverse Events (AEs)
Time frame: From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years)
Area Under the Concentration-time Curve (AUC) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Maximum Concentration (Cmax) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Clearance (CL) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Elimination Half-life (t1/2) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Volume of Distribution at Steady State (Vss) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against DNIB0600A
Time frame: Pre-DNIB0600A infusion on Day 1 of Cycles 1-4 (1cycle=21 days), at approximately 15-30 days after last infusion administration (overall up to approximately 2.5 years)
Results and safety
The study was stopped early (reason given: The primary objective of PFS did not meet pre-specified criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 37407274Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
- Derived from this study: PubMed 29401246Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, Moore KN, Mackowiak-Matejczyk B, Pikiel J, Ray-Coquard I, Trask P, Lin K, Schuth E, Vaze A, Choi Y, Marsters JC, Maslyar DJ, Lemahieu V, Wang Y, Humke EW, Liu JF. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023.
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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.
Clinical Trials study director
Genentech, Inc.
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNIB0600A and PLD in people with Ovarian Cancer, run by Genentech, Inc. at 36 sites in 7 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Spain, United Kingdom, France, Canada and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The primary objective of PFS did not meet pre-specified criteria.). Results are not available in the source record.
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?
Progression-free Survival According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: From baseline up to disease progression or death within 30 days of last study drug administration (overall up to approximately 2.5 years)). 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 NCT01991210, which also lists 2 linked publications.
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 Aug 2017.