Ovarian CancerPhase 1/2NCT01624493
BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients
A Phase 1/2 study testing Carboplatin, Gemcitabine and BNC105P in people with Ovarian Cancer, run by Hoosier Cancer Research Network at 6 sites in 3 countries.
Trial summary
This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse. 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?
- Carboplatin, Gemcitabine and BNC105P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 1/2
- 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
- Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma.
- Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
- Progression-free interval between 4 to 9 months after first line chemotherapy or 4 to 12 months after second-line chemotherapy with a platinum (cisplatin or carboplatin) based regimen.
- Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen.
- Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria.
- Subjects with clinically evident ascites and/or pleural effusions must be assessable by RECIST.
- Study treatment both planned and able to start within 7 days of randomisation
Who cannot join
- Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours)
- More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents).
- Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation
- Chemotherapy within 20 days prior to registration.
- Hormonal therapy or biologic therapy within 28 days prior to registration
- Concurrent treatment with any experimental drugs or other anti-cancer therapy.
Show all 22Show fewer
- Concurrent treatment with clopidogrel, ticlopidine, persantin and other antiplatelet agents
- Radiotherapy within 21 days prior to registration, or to greater than 15% of the bone marrow.
- Persistent toxic effects of previous chemotherapy of greater than Grade 1 severity (CTCAE v 4, appendix 8)
- Known brain or leptomeningeal disease (baseline CT brain or MRI is only required if there is clinical suspicion of central nervous system involvement).
- Subjects with other invasive malignancies who had (or have) any evidence of another cancer present within the last 3 years, with the exception of early stage non-melanoma skin cancer, carcinoma in situ of cervix, and synchronous endometrial cancer (stage 1 G1,2)
- Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (unstable angina, congestive cardiac failure, myocardial infarction) within the previous year, or cardiac ventricular arrhythmias requiring medication, or history of 2nd or 3rd degree atrioventricular conduction defects.
- Cerebrovascular accident or transient ischemic attack within 6 months prior to registration.
- Poorly controlled hypertension: systolic BP >150 or diastolic BP >100 mmHg. Antihypertensive medications are permitted but BP must be ≤150 systolic and ≤100 diastolic on 2 readings separated by at least 24 hours.
- Deep vein thrombosis, pulmonary embolism, within 6 months of registration or arterial thrombosis, or arterial embolism within 12 months prior to registration.
- Receiving full dose, therapeutic anti-coagulation with warfarin, related oral anti-coagulants or unfractionated or low molecular weight heparin. Low dose heparin given for prophylaxis, and aspirin at a dose ≤ 325 mg/day is acceptable.
- Significant infection including active hepatitis B, hepatitis C with abnormal liver function tests, or HIV. Testing for these is not mandatory. Screening for Hepatitis B should be as per institutional policy. Patients known to be Hep B surface antigen positive will be not be eligible even if on antiviral treatment.
- Serious medical or psychiatric conditions which might prevent management according to the protocol.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation
- Pregnancy, lactation, or inadequate contraception. Women must be post menopausal or sterile, or use two reliable means of contraception. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration.
- Life expectancy of less than 12 weeks.
- Carcinosarcoma and mucinous carcinoma
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Australia3 sites
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Peter MacCallum Cancer Centre
Melbourne, Victoria, 8006
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
United States2 sites
University of Chicago
Chicago, Illinois, 60637
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse
This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.
Read the detailed description
OUTLINE: This is a multi-center study.
BNC105P is a novel vascular disrupting agent (VDA) with promising preclinical activity combined with platinum or gemcitabine. The results of standard chemotherapy with carboplatin and gemcitabine for ovarian cancer relapsing within 12 months of an initial platinum-based regimen require improvement. This trial will determine the recommended dose and activity of BNC105P administered with carboplatin and gemcitabine.
PHASE I:
This trial uses a standard 3+3 design for allocating participants to a starting dose level in Phase I.
If dose level 1 is deemed to have acceptable toxicity then dose levels 2a and 2b can be opened at the same time. Dose level 3 will only open if both dose levels 2a and 2b are deemed to have acceptable toxicity.
The underlying assumptions for determining the recommended doses for the triple combination of carboplatin, gemcitabine and BNC105P are that the likely minimum doses required of each agent are carboplatin AUC 4, gemcitabine 800 mg/m2 and BNC105P 12 mg/m2. This corresponds to dose level 1.
PHASE II 1:1 RANDOMIZATION:
Carboplatin AUC 4 on day 1, gemcitabine 800 or 1000 mg/m2 on days 1 and 8 of a 21 day cycle for a maximum of 6 cycles.
OR
Carboplatin AUC 4 on day 1, gemcitabine 800 or 1000 mg/m2 on days 1 and day 8 with dose of BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles
Minimum follow up for 12 months
ECOG Performance Status for Phase I: 0-1; ECOG Performance Status for Phase II: 0-2
Life Expectancy: Less than 12 weeks
Hematopoietic (both phases):
- Platelet count ≥ 100 x 109/L
- ANC ≥ 1.5 x 109/L
- Haemoglobin > 9g/dl (can be post transfusion)
- INR ≤ 1.5 x ULN
Hepatic (both phases):
- Total Bilirubin ≤ 1.5 x the upper limit of normal (ULN)
- ALT ≤ 2.5 x ULN
Renal (both phases):
- Creatinine clearance ≥ 55 mL/min according to Cockcroft Gault formula
- If Calculated GFR is 50 - 54 mL/min an isotopic GFR may be performed. If the isotopic GFR is > 55ml/min, the patient will be eligible for the study but the calculated GFR will be used for dose calculation.
Cardiovascular (both phases):
- Normal left ventricular ejection fraction (LVEF), i.e. ≥ 50% on Gated Heart Pool Scan, or fractional shortening on echocardiogram ≥ institutional LLN performed within 2 months prior to randomisation
- Corrected QTc < 470 msec on ECG performed within 4 weeks prior to randomisation.
- Conditions
- Ovarian Cancer
- Being tested
- Carboplatin, Gemcitabine, BNC105P
- Keywords
- Vascular Disrupting Agents, BNC105P, Partially platinum sensitive
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.
GemcitabineDrug
Gemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles.
CarboplatinDrug
Carboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles.
GemcitabineDrug
Gemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles.
BNC105PDrug
BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase II Arm A | Experimental | Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P Receives: Drug: Carboplatin; Drug: Gemcitabine |
| Phase II Arm B | Experimental | Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P Receives: Drug: Carboplatin; Drug: Gemcitabine; Drug: BNC105P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine Maximum Tolerated Dose for Patients
To determine the recommended dose of BNC105P given with gemcitabine and carboplatin (maximum dose of BNC105P with no more than 1 DLT in 6 phase I participants)
Measured: 12 months
Phase II: Determine Objective Response Rate in Patients
To determine the objective response rate (ORR) in those with evaluable disease (ORR = CR, PR according to RECIST 1.1 and/or GCIG CA125 criteria) (percentage of those with measurable disease achieving CR or PR according to RECIST 1.1 and/or GCIG CA125 criteria)
Measured: 12 months
Secondary outcomes (5)
Progression Free and Overall Survival Distribution
To determine the progression free and overall survival distribution rates in this patient population
Measured: 12 months
Patient Side Effects and Tolerability
To determine the adverse event rates (Numbers (%) with G2-5 AE (NCI CTCAE v4.0)
Measured: 12 months
Patient Quality of Life Benefits
To determine the effects on aspects of health related quality of life (HRQL measured with FOSI and MOST), including symptom benefit (Numbers (%) with significant symptom benefit)
Measured: 12 months
Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine
Plasma will be collected to assess BNC105P pharmacokinetics on days 2 and 9 of cycle 1 only. Results will be compared with data from previous trials of BNC105P to determine their consistency and to establish if there is any major interaction with carboplatin and gemcitabine.
Measured: 12 months
Association of Biomarkers, Predictions and Outcomes
To determine the associations between baseline biomarkers, ORR, PFS, OS and AE
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionOct 2014
Why it stopped: Phase I was conducted Australia. Phase II not conducted and no US pts enrolled.
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, Australia New Zealand Gynaecological Oncology Group, Bionomics Limited
- Responsible party
- Sponsor
- Investigators
- Danny Rischin, Professor, Study chair, University of SydneyDaniela Matei, M.D., Principal investigator, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624493
- Sponsor's protocol ID
- GYN12-154 / ANZGOG-1103
- Status last verified
- Dec 2015
- First submitted
- 15 Jun 2012
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Danny Rischin, Daniela Matei, Jeffrey C. Goh, Michelle Margaret Vaughan, Philip James Beale, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, David C. Bibby, Jeremy Simpson, Elizabeth E. Doolin, Corinne E. Williams, Martin R. Stockler. A phase I/II study of the vascular disrupting agent BNC105P in combination with gemcitabine-carboplatin in partially platinum-sensitive ovarian cancer patients in first or second relapse: An international collaborative group trial of ANZGOG and HOG. J Clin Oncol 31, 2013 (suppl; abstr TPS5612) http://abstracts2.asco.org/AbstView_132_108013.html
Danny Rischin, Philip James Beale, Emma Caroline Rossi, Jeffrey C. Goh, Michelle Margaret Vaughan, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, Gabriel Kremmidiotis, Jeremy Andrew Simpson, Elizabeth E. Doolin, Tina C. Lavranos, Annabell F. Leske, Anne-Sophie Veillard, Martin R. Stockler, ANZGOG and HOG. A phase I study of the vascular-disrupting agent BNC105P in combination with gemcitabine-carboplatin in platinum-sensitive ovarian cancer patients in first or second relapse. J Clin Oncol 32:5s, 2014 (suppl; abstr 5524^). ACTRN12612000522819
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse
- ClinicalTrials.gov ID
- NCT01624493
- Acronym / sponsor ID
- GYN12-154 / ANZGOG-1103
- Conditions
- Ovarian Cancer
- Keywords
- Vascular Disrupting Agents, BNC105P, Partially platinum sensitive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Phase I was conducted Australia. Phase II not conducted and no US pts enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- University of Sydney, Australia New Zealand Gynaecological Oncology Group, Bionomics Limited
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jun 2012 (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 phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.
Detailed description
OUTLINE: This is a multi-center study.
BNC105P is a novel vascular disrupting agent (VDA) with promising preclinical activity combined with platinum or gemcitabine. The results of standard chemotherapy with carboplatin and gemcitabine for ovarian cancer relapsing within 12 months of an initial platinum-based regimen require improvement. This trial will determine the recommended dose and activity of BNC105P administered with carboplatin and gemcitabine.
PHASE I:
This trial uses a standard 3+3 design for allocating participants to a starting dose level in Phase I.
If dose level 1 is deemed to have acceptable toxicity then dose levels 2a and 2b can be opened at the same time. Dose level 3 will only open if both dose levels 2a and 2b are deemed to have acceptable toxicity.
The underlying assumptions for determining the recommended doses for the triple combination of carboplatin, gemcitabine and BNC105P are that the likely minimum doses required of each agent are carboplatin AUC 4, gemcitabine 800 mg/m2 and BNC105P 12 mg/m2. This corresponds to dose level 1.
PHASE II 1:1 RANDOMIZATION:
Carboplatin AUC 4 on day 1, gemcitabine 800 or 1000 mg/m2 on days 1 and 8 of a 21 day cycle for a maximum of 6 cycles.
OR
Carboplatin AUC 4 on day 1, gemcitabine 800 or 1000 mg/m2 on days 1 and day 8 with dose of BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles
Minimum follow up for 12 months
ECOG Performance Status for Phase I: 0-1; ECOG Performance Status for Phase II: 0-2
Life Expectancy: Less than 12 weeks
Hematopoietic (both phases):
- Platelet count ≥ 100 x 109/L
- ANC ≥ 1.5 x 109/L
- Haemoglobin > 9g/dl (can be post transfusion)
- INR ≤ 1.5 x ULN
Hepatic (both phases):
- Total Bilirubin ≤ 1.5 x the upper limit of normal (ULN)
- ALT ≤ 2.5 x ULN
Renal (both phases):
- Creatinine clearance ≥ 55 mL/min according to Cockcroft Gault formula
- If Calculated GFR is 50 - 54 mL/min an isotopic GFR may be performed. If the isotopic GFR is > 55ml/min, the patient will be eligible for the study but the calculated GFR will be used for dose calculation.
Cardiovascular (both phases):
- Normal left ventricular ejection fraction (LVEF), i.e. ≥ 50% on Gated Heart Pool Scan, or fractional shortening on echocardiogram ≥ institutional LLN performed within 2 months prior to randomisation
- Corrected QTc < 470 msec on ECG performed within 4 weeks prior to randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase II Arm A | Experimental | Drug: Carboplatin, Drug: GemcitabinePhase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P |
| Phase II Arm B | Experimental | Drug: Carboplatin, Drug: Gemcitabine, Drug: BNC105PPhase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P |
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)
- Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma.
- Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
- Progression-free interval between 4 to 9 months after first line chemotherapy or 4 to 12 months after second-line chemotherapy with a platinum (cisplatin or carboplatin) based regimen.
- Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen.
- Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria.
Key exclusion criteria (22 listed)
- Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours)
- More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents).
- Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation
- Chemotherapy within 20 days prior to registration.
- Hormonal therapy or biologic therapy within 28 days prior to registration
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 |
|---|---|---|
| CarboplatinCarboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles. | Drug | Phase II Arm A |
| GemcitabineGemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles. | Drug | Phase II Arm A |
| CarboplatinCarboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles. | Drug | Phase II Arm B |
| GemcitabineGemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles. | Drug | Phase II Arm B |
| BNC105PBNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles. | Drug | Phase II Arm B |
Primary outcome
Phase I: Determine Maximum Tolerated Dose for Patients
Time frame: 12 months
To determine the recommended dose of BNC105P given with gemcitabine and carboplatin (maximum dose of BNC105P with no more than 1 DLT in 6 phase I participants)
Phase II: Determine Objective Response Rate in Patients
Time frame: 12 months
To determine the objective response rate (ORR) in those with evaluable disease (ORR = CR, PR according to RECIST 1.1 and/or GCIG CA125 criteria) (percentage of those with measurable disease achieving CR or PR according to RECIST 1.1 and/or GCIG CA125 criteria)
5 secondary outcomes
Progression Free and Overall Survival Distribution
Time frame: 12 months
Patient Side Effects and Tolerability
Time frame: 12 months
Patient Quality of Life Benefits
Time frame: 12 months
Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine
Time frame: 12 months
Association of Biomarkers, Predictions and Outcomes
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- BackgroundDanny Rischin, Daniela Matei, Jeffrey C. Goh, Michelle Margaret Vaughan, Philip James Beale, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, David C. Bibby, Jeremy Simpson, Elizabeth E. Doolin, Corinne E. Williams, Martin R. Stockler. A phase I/II study of the vascular disrupting agent BNC105P in combination with gemcitabine-carboplatin in partially platinum-sensitive ovarian cancer patients in first or second relapse: An international collaborative group trial of ANZGOG and HOG. J Clin Oncol 31, 2013 (suppl; abstr TPS5612) http://abstracts2.asco.org/AbstView_132_108013.html
- BackgroundDanny Rischin, Philip James Beale, Emma Caroline Rossi, Jeffrey C. Goh, Michelle Margaret Vaughan, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, Gabriel Kremmidiotis, Jeremy Andrew Simpson, Elizabeth E. Doolin, Tina C. Lavranos, Annabell F. Leske, Anne-Sophie Veillard, Martin R. Stockler, ANZGOG and HOG. A phase I study of the vascular-disrupting agent BNC105P in combination with gemcitabine-carboplatin in platinum-sensitive ovarian cancer patients in first or second relapse. J Clin Oncol 32:5s, 2014 (suppl; abstr 5524^). ACTRN12612000522819
- Hoosier Oncology Group WebsiteLink provided by the sponsor.
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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.
Danny Rischin, Professor study chair
University of Sydney
Daniela Matei, M.D. principal investigator
Hoosier Cancer Research Network
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carboplatin, Gemcitabine and BNC105P in people with Ovarian Cancer, run by Hoosier Cancer Research Network at 6 sites in 3 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 22 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: withdrawn, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, United States, New Zealand. 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 combined 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Phase I: Determine Maximum Tolerated Dose for Patients (time frame: 12 months). The study lists 2 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 NCT01624493, 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 23 Dec 2015.