Clinical trial · Interventional
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Lymphopenia | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| TXA127 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- TXA127 100 ug/kg
- description
- Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
- interventionNames
- Drug: TXA127
- type
- EXPERIMENTAL
- label
- TXA127 300 ug/kg
- description
- Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females at least 18 years of age with ovarian carcinoma who are one of the following: * Newly diagnosed with ovarian cancer and chemotherapy naïve, or * Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or * Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit. * Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests * Adequate blood coagulation parameters as measured by standard blood tests for coagulation Exclusion Criteria: * Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria * Significant unstable cardiovascular disease * Uncontrolled high blood pressure * Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists * Evidence of metastatic disease to the bone * Metastatic disease to the CNS requiring treatment or radiation therapy * Uncontrolled infection(s) * Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years * Concurrent use of hematopoietic or erythropoietic agents
References
Publications (2)
- BACKGROUNDRodgers KE, Oliver J, diZerega GS. Phase I/II dose escalation study of angiotensin 1-7 [A(1-7)] administered before and after chemotherapy in patients with newly diagnosed breast cancer. Cancer Chemother Pharmacol. 2006 May;57(5):559-68. doi: 10.1007/s00280-005-0078-4. Epub 2005 Aug 12. PMID 16096787
- BACKGROUNDEllefson DD, diZerega GS, Espinoza T, Roda N, Maldonado S, Rodgers KE. Synergistic effects of co-administration of angiotensin 1-7 and Neupogen on hematopoietic recovery in mice. Cancer Chemother Pharmacol. 2004 Jan;53(1):15-24. doi: 10.1007/s00280-003-0710-0. Epub 2003 Oct 16. PMID 14569417