Platinum Resistant Ovarian CancerPhase 2/3NCT02641639
FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer
A Phase 2/3 study testing Fosbretabulin tromethamine in people with Platinum Resistant Ovarian Cancer, run by Mateon Therapeutics at 40 sites in 3 countries.
Trial summary
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase 2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum Resistant Ovarian Cancer
- What is being tested?
- Fosbretabulin tromethamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 40 sitesin 3 countries
- Study dates
- Jun 2016to Oct 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent form (ICF)
- Age ≥ 18 years (Age ≥ 19 years if required by local regulatory authorities)
- ECOG PS of 0-1
- Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer in recurrent stage
- prOC (platinum-resistant ovarian cancers) defined as progression within > 1 to < 6 months (+ 2 weeks) of completing previous cycle of primary platinum-based therapy, or during or within < 6 months (+ 2 weeks) of starting additional platinum based therapies
- Received ≥ 1 but ≤ 3 prior platinum-based regimens
Show all 19Show fewer
- Measurable disease according to RECIST 1.1
- Left ventricular ejection fraction (LVEF) greater than or equal to at least 45% at baseline assessment if subject is receiving PLD, and/or anthracycline is a concomitant medication
- No evidence of active (progressing) brain metastasis. (Treated brain metastasis allowed with a posttreatment magnetic resonance imaging (MRI) or Computed Tomography (CT) of brain showing no active (progressing) brain metastasis). Treatment of brain metastasis may include surgery, radiosurgery (linear accelerator (LINAC), gamma knife), or whole brain irradiation. Surgery for brain metastasis must be > 8 weeks from study entry
- Hemoglobin > 9 g/dl. Erythroid growth factors should not have been used in the 2 weeks prior to study entry. Red blood cell transfusions are permitted to maintain the hemoglobin level > 9 g/dl
- Adequate bone marrow function in the investigator's opinion
- Adequate hepatic function defined by the following:
- Total bilirubin < 2 x Upper Limit of Normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN for the referenced lab (< 5 X ULN for subjects with liver metastases)
- Adequate renal function defined by the following:
- Serum creatinine < 2 X ULN for the referenced lab
- Subjects of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing a highly effective form of contraception
- At least 2 weeks since prior radiotherapy and has recovered from any Grade 3 toxicities
- Life expectancy ≥ 12 weeks
Who cannot join
- Subjects who have received prior CA4P therapy
- Previously having failed treatment with bevacizumab combined with the intended PCC.
- For clarity: Investigators should not select a bevacizumab + PCC combination for the FOCUS trial if the patient has previously failed that same regimen, however they may select a new PCC regimen to combine with bevacizumab. For example, a patient who failed bevacizumab + weekly paclitaxel would be allowed to enroll in FOCUS only if they are assigned to bevacizumab + PLD for the study.
- Previous treatment with greater than three traditional chemotherapy treatment regimens
- Untreated brain metastasis or leptomeningeal brain metastasis
- Solid organ or bone marrow transplant
Show all 28Show fewer
- Primary platinum-refractory disease (defined as progression during dosing or within one (1) month of completing the last cycle of patients first platinum-containing regimen)
- > Grade 2 peripheral neuropathy
- Current thrombotic or hemorrhagic disorder/event or history of prior event within 6 months of start of Screening
- History of prior cerebrovascular event, (including transient ischemic attack) within 6 months of start of Screening
- Recent history (within 6 months of start of Screening) of angina pectoris, myocardial infarction (including non-Q wave MI), or NYHA Class III and IV congestive heart failure
- History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, benign PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG
- Known uncontrolled HIV infection
- Uncontrolled, clinically significant active infection
- Serious non-healing wound, ulcer or bone fracture
- Subjects with known hypersensitivity to any of the components of CA4P, paclitaxel, PLD, or bevacizumab (paclitaxel and PLD dependent on whether PI plans they will be dosed with that PCC)
- Subjects who are currently or planning on receiving concurrent investigational therapy or who have received investigational therapy for any indication within 30 days of the first scheduled day of dosing
- Subjects with any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and participate in the study, or to interfere with the interpretation of the study results
- Subjects with other invasive malignancies, with the exception of non-melanoma skin cancer, or with previous cancer treatment that contraindicates this protocol therapy within last 3 years
- Prior radiation therapy to the pelvis or abdomen within 4 weeks of entry into the study
- History of fistula, gastrointestinal (GI) perforation or intra-abdominal abscess, or invasive disease/metastases of the bowel which in the investigators opinion may increase the risk of GI perforation with bevacizumab treatment.
- Uncontrolled hypertension (HTN)
- Sustained BP greater than 150 mmHG SBP / 100 mmHG DBP
- Uncontrolled elevated proteinuria levels in the investigator's opinion
- Corrected QT interval ([QTc] Fridericia) > 480 ms
- Significant vascular disease or recent peripheral arterial thrombosis
- Subjects with active bleeding or pathologic conditions that carry high risk of bleeding
- Subjects who are pregnant or lactating
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States36 sites
Lehigh Valley Hospital, John and Dorothy Morgan Cancer Center; Affiliate Memorial Sloan Kettering
Allentown, Pennsylvania, 18103
Augusta University
Augusta, Georgia, 30912
Texas Oncology, P.A.
Austin, Texas, 78731
Mercy Medical Center; The Institute for Cancer Care
Baltimore, Maryland, 21202
Texas Oncology
Bedford, Texas, 76022
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35249
Gabrail Cancer Center
Canton, Ohio, 44718
Dallas County Hospital District d/b/a Parkland Health and Hospital System
Dallas, Texas, 75235
Simmons Comprehensive Cancer Center; UT Southwestern Medical Center
Dallas, Texas, 75235
Texas Oncology, P.A.
Dallas, Texas, 75246
Hartford Health Care Cancer Institute; Affiliate Memorial Sloan Kettering
Hartford, Connecticut, 06102
HCA Midwest Division - Sarah Cannon Cancer Institute
Kansas City, Missouri, 64132
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228
Oncology Institute of Hope and Innovation
Lynwood, California, 90262
Sylvester Comprehensive Cancer Center University of Miami
Miami, Florida, 33136
Baptist Health Medical Group Oncology, LLC
Miami, Florida, 33176
Mitchell Cancer Institute - USA Health System
Mobile, Alabama, 36604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oklahoma Heath Sciences Center - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of California Irvine
Orange, California, 92868
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
OHSU Center for Women's Health & Knight Cancer Institute
Portland, Oregon, 97239
Texas Oncology San Antonio
San Antonio, Texas, 78229
California Pacific Medical Center, Research Institute
San Francisco, California, 94115
Sansum Clinic
Santa Barbara, California, 93105
Maine Medical Center
Scarborough, Maine, 04074
Gibbs Cancer Center & Research Institute Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Willamette Valley Cancer Institute
Springfield, Oregon, 97477
Stamford Hospital - Bennett Cancer Center
Stamford, Connecticut, 06904
Moffitt Cancer Center
Tampa, Florida, 33612
Texas Oncology, P.A.
The Woodlands, Texas, 77380
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711
University of Arizona Cancer Center
Tucson, Arizona, 85724
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146
Texas Oncology, P.A.
Tyler, Texas, 75702
Germany3 sites
Universitätsklinikum Erlangen
Erlangen, D-91054
Universitätsklinikum Essen (AöR) Klinik für Frauenheilkunde und Geburtshilfe
Essen, 45147
Universitäts-Frauenklinik Dept. für Frauengesundheit
Tübingen, 72076
About this study
Official title: FOCUS: A Multicenter, Multinational, Double-Blind, 2-Arm, Randomized, Phase 2/3, Study of Physician's Choice Chemotherapy ([PCC] Weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo for Subjects With Platinum-Resistant, Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase 2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC). Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs. paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study, consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.
Read the detailed description
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase 2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC). Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs. paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study, consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.
All subjects randomized will receive bevacizumab 10 mg/kg intravenously (IV) on Days 1 and 15, repeated every 4 weeks (q4wk) and PCC with paclitaxel 80 mg/m2 IV on Days 1, 8, 15 and 22, repeated q4wk, or paclitaxel 80 mg/m2 IV on Days 1, 8, 15, repeated q4wk or PLD 40 mg/m2 IV on Day 1, repeated q4wk. Subjects in the Treatment Arm will also receive CA4P 60 mg/m2 on the same day as bevacizumab (Days 1 and 15, repeated q4wk), while subjects in the Control Arm will receive placebo on those days.
Order of dosing will follow the guidance listed below during this study when bevacizumab and CA4P / Placebo are dosed the same day as PCC,
- Bevacizumab followed by CA4P / Placebo followed after 1-3 hours by paclitaxel,
- PLD followed by bevacizumab followed by CA4P / Placebo Subjects will continue randomized treatment until disease progression, unacceptable toxicity, investigator decision, withdrawal of consent, or sponsor discontinues study for any reason. Subjects will undergo tumor assessments (RECIST) at baseline and every 8 weeks and CA-125 levels at baseline and every 4 weeks.
The primary endpoint is PFS. Secondary endpoints include ORR, OS, proportion of subjects who remain progression free at 6, 9, and 12 months, and safety. Endpoints will be compared between the Treatment Arm and the Control arm. The study duration is estimated to last approximately 3 years.
This study will have 2 parts with the same overall design. Part 1 will enroll up to approximately 80 subjects and will include multiple interim analyses to test the safety and efficacy assumptions in this specific subject population. Upon meeting certain efficacy criteria in Part 1, the protocol will be amended and additional sites added in order to enroll an additional 356 subjects into Part 2 of the study. Subjects enrolled in Part 2 will be analyzed separately and used as a stand-alone confirmatory efficacy study.
- Conditions
- Platinum Resistant Ovarian Cancer
- Being tested
- Fosbretabulin tromethamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosbretabulin tromethamineDrug
Also called Fosbretabulin Combretastatin A4-Phosphate, CA4P
CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
PlaceboDrug
Also called Saline for infusion
Saline for infusion
| Study group | Role | What they receive |
|---|---|---|
| Fosbretabulin tromethamine | Active comparator | Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) plus bevacizumab and CA4P Receives: Drug: Fosbretabulin tromethamine |
| Placebo | Placebo comparator | Physician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) plus bevacizumab and placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The primary efficacy parameter in this study is statistically meaningful PFS, defined as the time from the date of randomization until patient discontinuation or death from any cause.
Measured: 12 Months
Secondary outcomes (4)
Improvement in Objective Response Rate
Improvement in objective response rate (ORR). The ORR will be defined as the proportion of subjects with a confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1 criteria, based upon the best response. The ORR will be determined based on investigator assessment according to RECIST 1.1 criteria and/or GCIG CA-125 criteria.
Measured: 12 Months
Overall Survival (OS)
Evaluation of overall survival (OS)
Measured: 12 Months
Proportion of Subjects Who Remain Progression-free at 12 Months
Assessment of the proportion of subjects who remain progression-free at 12 months on the regimen of PCC plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo
Measured: 12 Months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of PCC Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo
To evaluate the Incidence of Treatment-Emergent Adverse Events of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo as measured by aggregate reporting of the number of patient with abnormal findings on (physical exams, vital signs, laboratory measures, ECG, Eastern Cooperative Oncology Group (ECOG) performance status (PS)) and/or analysis of the incidence of adverse events (AEs) using the National Cancer Institute (NCI)-Common Terminology Criteria for AEs (CTCAE) version 4.03.
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 posted29 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: The study was terminated early due to the lack of efficacy and the study sponsor's decision to no longer continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Platinum Resistant 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harish Dave, MD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641639
- Sponsor's protocol ID
- OX4325
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2015
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS: A Multicenter, Multinational, Double-Blind, 2-Arm, Randomized, Phase 2/3, Study of Physician's Choice Chemotherapy ([PCC] Weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo for Subjects With Platinum-Resistant, Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT02641639
- Acronym / sponsor ID
- OX4325
- Conditions
- Platinum Resistant Ovarian Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to the lack of efficacy and the study sponsor's decision to no longer continue the study
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase 2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC). Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs. paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study, consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.
Detailed description
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase 2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC). Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs. paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study, consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.
All subjects randomized will receive bevacizumab 10 mg/kg intravenously (IV) on Days 1 and 15, repeated every 4 weeks (q4wk) and PCC with paclitaxel 80 mg/m2 IV on Days 1, 8, 15 and 22, repeated q4wk, or paclitaxel 80 mg/m2 IV on Days 1, 8, 15, repeated q4wk or PLD 40 mg/m2 IV on Day 1, repeated q4wk. Subjects in the Treatment Arm will also receive CA4P 60 mg/m2 on the same day as bevacizumab (Days 1 and 15, repeated q4wk), while subjects in the Control Arm will receive placebo on those days.
Order of dosing will follow the guidance listed below during this study when bevacizumab and CA4P / Placebo are dosed the same day as PCC,
- Bevacizumab followed by CA4P / Placebo followed after 1-3 hours by paclitaxel,
- PLD followed by bevacizumab followed by CA4P / Placebo Subjects will continue randomized treatment until disease progression, unacceptable toxicity, investigator decision, withdrawal of consent, or sponsor discontinues study for any reason. Subjects will undergo tumor assessments (RECIST) at baseline and every 8 weeks and CA-125 levels at baseline and every 4 weeks.
The primary endpoint is PFS. Secondary endpoints include ORR, OS, proportion of subjects who remain progression free at 6, 9, and 12 months, and safety. Endpoints will be compared between the Treatment Arm and the Control arm. The study duration is estimated to last approximately 3 years.
This study will have 2 parts with the same overall design. Part 1 will enroll up to approximately 80 subjects and will include multiple interim analyses to test the safety and efficacy assumptions in this specific subject population. Upon meeting certain efficacy criteria in Part 1, the protocol will be amended and additional sites added in order to enroll an additional 356 subjects into Part 2 of the study. Subjects enrolled in Part 2 will be analyzed separately and used as a stand-alone confirmatory efficacy study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosbretabulin tromethamine | Active comparator | Drug: Fosbretabulin tromethaminePhysician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) plus bevacizumab and CA4P |
| Placebo | Placebo comparator | Drug: PlaceboPhysician's choice chemotherapy (weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) plus bevacizumab and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent form (ICF)
- Age ≥ 18 years (Age ≥ 19 years if required by local regulatory authorities)
- ECOG PS of 0-1
- Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer in recurrent stage
- prOC (platinum-resistant ovarian cancers) defined as progression within > 1 to < 6 months (+ 2 weeks) of completing previous cycle of primary platinum-based therapy, or during or within < 6 months (+ 2 weeks) of starting additional platinum based therapies
Key exclusion criteria (28 listed)
- Subjects who have received prior CA4P therapy
- Previously having failed treatment with bevacizumab combined with the intended PCC.
- Previous treatment with greater than three traditional chemotherapy treatment regimens
- Untreated brain metastasis or leptomeningeal brain metastasis
- Solid organ or bone marrow transplant
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 |
|---|---|---|
| Fosbretabulin tromethamineAlso: Fosbretabulin Combretastatin A4-Phosphate, CA4PCA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors. | Drug | Fosbretabulin tromethamine |
| PlaceboAlso: Saline for infusionSaline for infusion | Drug | Placebo |
Primary outcome
Progression Free Survival
Time frame: 12 Months
The primary efficacy parameter in this study is statistically meaningful PFS, defined as the time from the date of randomization until patient discontinuation or death from any cause.
4 secondary outcomes
Improvement in Objective Response Rate
Time frame: 12 Months
Overall Survival (OS)
Time frame: 12 Months
Proportion of Subjects Who Remain Progression-free at 12 Months
Time frame: 12 Months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of PCC Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Harish Dave, MD study director
Medical Monitor
40 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fosbretabulin tromethamine in people with Platinum Resistant Ovarian Cancer, run by Mateon Therapeutics at 40 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 19 inclusion and 28 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Belgium. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 12 Months). 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 24 Mar 2025.