TerminatedPhase 1

Phase 1, First-in-human Study of Oral TP-1287 in Patients with Advanced Solid Tumors

Stopped: Sponsor's decision to terminate further development of the program.

United States74 participantsStarted 2018-12-26

Plain-language summary

TP-1287 is an oral phosphate prodrug of the CDK9 inhibitor, alvocidib. This is a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For Dose Escalation:
✓. Have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor excluding tumor types with rapid cell turnover, ie, small cell cancer (lung and extra pulmonary), inflammatory breast cancer (IBC), medulloblastoma, neuroblastoma and melanoma with extensive liver metastasis (greater than or equal to 50% of the liver involved; patients with melanoma and metastasis to less than 50% of the liver are eligible)
✓. Be refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
✓. For Dose Expansion:
✓. Patients who have histologically confirmed locally advanced or metastatic unresectable Ewing sarcoma
✓. Have received at least one prior line of treatment (but no more than 5 prior lines) including an anthracycline.
✓. Have one or more measurable tumors measurable or evaluable as outlined by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1

Exclusion criteria

What they're measuring

During Dose Escalation: Incidence of dose-limiting toxicities (DLTs) and treatment emergent adverse events

Timeframe: 21 days

During Dose Escalation: Determine maximum tolerated dose (MTD)

Timeframe: 20 months

During Dose Expansion: Determine preliminary antitumor activity of TP-1287 in terms of objective response rate (ORR) when administered at the Recommended Phase 2 Dose (RP2D) in patients with sarcoma

Timeframe: 20 months

During Dose Expansion: Determine preliminary antitumor activity of TP-1287 in terms of clinical benefit rate (CBR) at week 16 when administered at the RP2D in patients with sarcoma.

Timeframe: 16 weeks

Trial details

NCT IDNCT03604783

SponsorSumitomo Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-10

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For Dose Escalation:
✓. Have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor excluding tumor types with rapid cell turnover, ie, small cell cancer (lung and extra pulmonary), inflammatory breast cancer (IBC), medulloblastoma, neuroblastoma and melanoma with extensive liver metastasis (greater than or equal to 50% of the liver involved; patients with melanoma and metastasis to less than 50% of the liver are eligible)
✓. Be refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
✓. For Dose Expansion:
✓. Patients who have histologically confirmed locally advanced or metastatic unresectable Ewing sarcoma
✓. Have received at least one prior line of treatment (but no more than 5 prior lines) including an anthracycline.
✓. Have one or more measurable tumors measurable or evaluable as outlined by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1

Exclusion criteria

What they're measuring

During Dose Escalation: Incidence of dose-limiting toxicities (DLTs) and treatment emergent adverse events

Timeframe: 21 days

During Dose Escalation: Determine maximum tolerated dose (MTD)

Timeframe: 20 months

During Dose Expansion: Determine preliminary antitumor activity of TP-1287 in terms of objective response rate (ORR) when administered at the Recommended Phase 2 Dose (RP2D) in patients with sarcoma

Timeframe: 20 months

During Dose Expansion: Determine preliminary antitumor activity of TP-1287 in terms of clinical benefit rate (CBR) at week 16 when administered at the RP2D in patients with sarcoma.

Timeframe: 16 weeks