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.

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

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.

Part A: Dose Escalation 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.

Part B: Expansion Cohort of Cantrixil

Peggy and Charles Stephenson Cancer Center, OU Health Sciences Center

Lifespan Cancer Institute, Rhode Island Hospital

Mary Crowley Cancer Research Center

Westmead Adults Hospital

ICON Cancer Care

Flinders Medical Centre

Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.

Phase I Study of Intra-peritoneal Cantrixil in Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.

Determination of the MTD of Cantrixil using standard safety monitoring assessments when administered as a monotherapy.

Description of the PK of Cantrixil when administered as a monotherapy and in combination with standard chemotherapy agent(s)

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.

The time to paracentesis will be measured as the time from treatment initiation until the next paracentesis event for ascites.

The volume of abdominal fluid will be measured by estimating the volume of malignant ascites drained at each paracentesis event.

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

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.

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 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 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 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.

Kazia Therapeutics Limited

Receives placebo injections daily via subcutaneous injection

Osteoporosis

Osteoporosis, Postmenopausal

PTHrP(1-36) starting at 500 micrograms, then increasing by 125 micrograms up to a maximum of 1,500 micrograms.

Parathyroid Hormone-related Protein

Placebo drug via subcutaneous injection in single blinded fashion daily for 3 weeks

Placebo

University of Pittsburgh's clinical research study website

hypophosphatemia/повраќање

Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.

3-Week Parathyroid Hormone-related Protein (PTHrP) Dose Escalation Study in Post-Menopausal Women

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