Clinical trial · Interventional
Study of TRC102 in Combination With Pemetrexed in Cancer Patients
Open Label Phase 1 Dose Finding Study of TRC102 in Combination With Pemetrexed in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable
NCT00692159CI-TRIAL-00003897completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 study is being performed to evaluate the safety and tolerability of TRC102 in combination with Alimta. In addition to safety, this study will also evaluate pharmacokinetics and tumor response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRC102 + pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Dose finding single arm
- interventionNames
- Drug: TRC102 + pemetrexed
Primary outcomes (1)
- measure
- To determine the recommended Phase 2 dose and overall safety and tolerability of TRC102 when given alone and when combined with pemetrexed for the treatment of patients with advanced solid or metastatic cancer for whom curative therapy is unavailable.
- timeFrame
- Study completion
Secondary outcomes (1)
- measure
- Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics
- timeFrame
- Study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has given informed consent * The patient is willing and able to abide by the protocol * The patient has cancer and curative therapy is unavailable or standard therapy has failed * The patient is at least 18 years of age * The patient has adequate ability to perform activities of daily living * The patient has recovered from significant toxicities of previous therapy * The patient has adequate organ function as assessed by laboratory testing Exclusion Criteria: * The patient has had prior treatment with high-dose chemotherapy requiring stem cell rescue * The patient is currently on treatment on another therapeutic clinical trial or has received an investigational drug within 4 weeks prior to first dose on this study * The patient has had prior surgery, radiation or systemic therapy within 4 weeks of starting the study * The patient has a history of CNS cancer * The patient has an unstable medical condition including (not limited to) cardiac disease, HIV/AIDS, history of stroke, hepatitis or significant paricardial, pleural or peritoneal effusion * The patient is pregnant or breastfeeding
References
Publications (1)
- DERIVEDGordon MS, Rosen LS, Mendelson D, Ramanathan RK, Goldman J, Liu L, Xu Y, Gerson SL, Anthony SP, Figg WD, Spencer S, Adams BJ, Theuer CP, Leigh BR, Weiss GJ. A phase 1 study of TRC102, an inhibitor of base excision repair, and pemetrexed in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):714-23. doi: 10.1007/s10637-012-9876-9. Epub 2012 Sep 29. PMID 23054206