Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.
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|ClinicalTrials.gov Identifier: NCT02903771|
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms||Drug: Part A: Dose Escalation of Cantrixil Drug: Part B: Expansion Cohort of Cantrixil||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intra-peritoneal Cantrixil in Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Part A and Part B
Part A (Dose Escalation):
Part A is a Dose Escalation study to determine the Maximum Tolerated Dose of Cantrixil as a monotherapy.
The tolerance of Cantrixil in combination with standard chemotherapy agents will also be examined.
Part B (Expansion Cohort):
An expansion cohort of an additional 12 patients will be recruited at the MTD.
Drug: Part A: Dose Escalation of Cantrixil
Cantrixil will be administered via the intraperitoneal route only. The dose of study drug that each participant will receive will depend on how far the study has progressed when the participant enrols. There are 9 potential doses of Cantrixil, they are 0.06, 0.12, 0.24 (starting dose), 0.6, 1.25, 2.5, 5, 10, or 20 mg/kg. The dose each participant receives will remain the same during the study, unless it needs to be reduced for safety reasons. The dose will not be increased.
Each participant will receive the study drug once a week during the first two cycles; each cycle is 21-days (three weeks); the MTD will be determined during Cycle 1 only. If after two cycles of monotherapy, the patient tolerates Cantrixil adequately, they may continue to receive Cantrixil once a week and will also begin combination chemotherapy for another 6 cycles. Participants will receive no more than 8 cycles of study drug.
Other Name: TRX-E-002-1 in 20% SBECD
Drug: Part B: Expansion Cohort of Cantrixil
Once the MTD has been established, an expansion cohort will be recruited at the MTD. An additional 12 patients will be recruited in this cohort on top of those recruited in Part A at the MTD. These patients will be subjected to the same intervention described in Part A with 2 cycles of monotherapy followed by up to 6 cycles of combination therapy.
Other Name: TRX-E-002-1 in 20% SBECD
- Determination of the Maximum Tolerated Dose (MTD) [ Time Frame: During Cycle 1 (21 days) ]Determination of the MTD of Cantrixil using standard safety monitoring assessments when administered as a monotherapy.
- Pharmacokinetic (PK) profile of Cantrixil after intra-peritoneal (IP) administration [ Time Frame: 0-24 hours after administration ]Description of the PK of Cantrixil when administered as a monotherapy and in combination with standard chemotherapy agent(s)
- Time to Progression (TTP) [ Time Frame: Baseline to End of Study (maximum 36 weeks) ]TTP will be measured as the time from treatment start until objective tumour disease progression as defined by RECIST version 1.1 and/or GCIG criteria, but does not include deaths.
- Time to Paracentesis [ Time Frame: Baseline to End of Study (maximum 36 weeks) ]The time to paracentesis will be measured as the time from treatment initiation until the next paracentesis event for ascites.
- Volume of Malignant Ascites [ Time Frame: Baseline to End of Study (maximum 36 weeks) ]The volume of abdominal fluid will be measured by estimating the volume of malignant ascites drained at each paracentesis event.
- Disease Response [ Time Frame: Baseline to End of Study (maximum 36 weeks) ]Disease response will be measured using RECIST version 1.1 criteria; during Follow-up, response may be also assessed using the Gynecological Cancer Intergroup (GCIG) response criteria that incorporates CA-125 measurements
- CA-125 level [ Time Frame: Baseline to End of Study (maximum 36 weeks) ]Concentration of CA-125 in peripheral blood will be assayed in local laboratories using locally validated assays at baseline and then weekly during treatment, at the End of Therapy and during Follow-up.
- Tolerance of Increased Dose Frequency [ Time Frame: Baseline to End of Study (maximum 36 weeks) ]Determination of the optimum dose and administration schedule (i.e. weekly vs twice weekly administration) using standard safety monitoring assessments, PK measurements and tolerability of delivery in the study centre.
- Enumeration of Circulating Epithelial Tumour Cells (CETC) [ Time Frame: Baseline, End of Monotherapy (up to 6 weeks), End of Combination Therapy (up to 24 weeks) ]Enumeration of CETC in peripheral blood and malignant ascites (if present) will be assayed using the MAINTRAC® CETC Count method by Genostics or similar methodology.
- Clonogenicity of Circulating Epithelial Tumour Cells (CETC) [ Time Frame: Baseline, End of Monotherapy (up to 6 weeks), End of Combination Therapy (up to 24 weeks) ]Clonogenicity of CETCs in peripheral blood and malignant ascites (if present) will be measured using the MAINTRAC® Tumour Sphere Units assay by Genostics or similar methodology.
- Expression of Stem Cell Markers [ Time Frame: Baseline, End of Monotherapy (up to 6 weeks), End of Combination Therapy (up to 24 weeks) ]Expression of stem cell markers CD44 and ALDH1 in the isolated colonies will be measured using fluorescein isothiocyanate-labelled (FITC-labelled) or alternatively labelled antibodies and scanning fluorescent microscopy techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903771
|Contact: Dr James Garner, MBBS MBA||+612 email@example.com|
|Contact: Daniel Berg||+612 firstname.lastname@example.org|
|United States, Oklahoma|
|Peggy and Charles Stephenson Cancer Center, OU Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator: Dr K Moore|
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|Lifespan Cancer Institute, Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
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|Australia, New South Wales|
|Westmead Adults Hospital||Recruiting|
|Westmead, New South Wales, Australia, 2145|
|Principal Investigator: Prof Paul Harnett, MBBS FRACP PhD|
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|South Brisbane, Queensland, Australia, 4101|
|Principal Investigator: Jermaine (Jim) Coward, MBBS MRCP FRACP PhD|
|Australia, South Australia|
|Flinders Medical Centre||Recruiting|
|Adelaide, South Australia, Australia|
|Principal Investigator: Dr G Kichenadasse|
|Principal Investigator:||A/Prof Jermaine (Jim) Coward, BSc, MBBS, PhD, MRCP, FRACP||ICON Cancer Care, Queensland, Australia|
|Principal Investigator:||Dr Don Dizon, MD, FACP||Lifespan Cancer Institute, Rhode Island, USA|