Study of TRC102 in Combination With Pemetrexed in Cancer Patients

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692159
• Other study ID #: 102ST101
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2008
• Last updated: September 8, 2010
• Start date: June 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Tracon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm

Intervention

Drug:
• TRC102 + pemetrexed
Oral TRC102 solution + IV pemetrexed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tracon Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Study completion	Yes
Secondary	Characterize pharmacokinetics, assess anti-tumor activity, and assess pharmacodynamics		Study completion	Yes

External Links

•   TRACON Pharmaceuticals Inc. Web Site