No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
This trial is looking for adults with hard-to-treat solid tumors. Participants will take a medication called AOH1996 to see how it affects their tumors and to find the best dose.
Are You a Good Fit for This Trial?
Must not be takingWarfarin
You may be able to join if
I am at least 18 years old
I have a solid tumor that is not responding to standard treatments
I understand and agree to participate in the study
I can provide archived tissue samples if needed
I have a life expectancy of more than 3 months
I have a good performance status
I will use contraception if I can become pregnant or father a child
You may not be able to join if
I cannot take oral medications
I am pregnant or breastfeeding
I have taken certain medications that interfere with the study
I have a known allergy to the study medication or its components
I have another active cancer besides certain exceptions
I have had a major health issue that risks my safety
I cannot comply with the study's procedures
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
Informed Consent and Willingness to Participate
* 1\. Documented informed consent by the participant
* 2\. Willingness to permit study team to obtain and use archival tissue, if already existing
Age Criteria, Performance Status and Life Expectancy
* 3\. Age: ≥ 18 years
* 4\. …
Inclusion Criteria:
Informed Consent and Willingness to Participate
* 1\. Documented informed consent by the participant
* 2\. Willingness to permit study team to obtain and use archival tissue, if already existing
Age Criteria, Performance Status and Life Expectancy
* 3\. Age: ≥ 18 years
* 4\. ECOG performance status ≤ 2
* 5\. Life expectancy of \> 3 months
Nature of Illness and Treatment History \_\_6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR TKI + AOH1996) cohort: patients with stable disease or better on EGFR TKI for at least 2 months)
Contraception
\_\_7. Agreement by females and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study medication. See Appendix B for guidelines.
\- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
Laboratory Criteria (to be performed within 14 days prior to Day 1)
* 8\. ANC ≥ 1,500/mm3
* 9\. Platelets ≥ 100,000/mm3 :
* 10\. Total serum bilirubin ≤ 1.5 x ULN
* 11\. AST =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
* 12\. ALT =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
* 13\. Creatinine clearance of ≥ 60 mL/min per 24 hour urine or the Cockcroft-Gault
* 14\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Exclusion Criteria
Concomitant Medications/Therapies \_\_1. Dietary/herbal supplements
* 2\. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
* 3\. Warfarin
* 4\. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
* 5\. Strong inhibitors or inducers of CYP2C9
* 6\. Strong inhibitors or inducers of CYP3A
Other Illnesses and Conditions
* 7\. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
* 8\. Women who are or are planning to become pregnant or breastfeed
* 9\. Known allergy to any of the components within the study agents and/or their excipients.
* 10\. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
* 11\. Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection).
Noncompliance
\_\_12. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
\*\*Eligibility should be confirmed per institutional policies.
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